New FDA Approvals

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Leqselvi for Alopecia Areata: The FDA has approved deuruxolitinib (Leqselvi) as a first-line treatment for adults with moderate to severe alopecia areata (AA). Developed by Sun Pharma, this oral selective inhibitor of Janus kinases JAK1 and JAK2 is typically dosed at 8 mg twice daily. The approval, based on the THRIVE-AA1 and THRIVE-AA2 trials, marks an important addition to limited treatment options for AA, which has significant psychological impacts.

Femlyv Dissolvable Birth Control: The FDA has approved norethindrone acetate and ethinyl estradiol (Femlyv) as an oral dissolvable birth control pill, expanding access for those who have difficulty swallowing. This form of hormonal birth control, in use since 1968 as a swallowable tablet, also helps manage conditions like endometriosis and PMDD. The approval, based on a study of 743 women, offers a new option with common side effects like headache and nausea.

Brineura for Batten Disease: The FDA has expanded the indication for cerliponase alfa (Brineura) to treat neuronal ceroid lipofuscinosis type 2 (CLN2 disease) in children under 3 years of age. Developed by BioMarin Pharmaceutical, this enzyme replacement therapy, initially approved in 2017, is administered by infusion into the brain. The expanded approval was based on a phase 2 trial showing reduced motor function decline and delayed disease onset.

Erzofri for Schizophrenia: The FDA has approved paliperidone palmitate (Erzofri) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults. This long-acting injectable (LAI) antipsychotic, administered once a month, improves patient adherence by reducing dosing frequency. Developed by Luye Pharma Group, it was granted a U.S. patent in 2023 and approved under the 505(b)(2) pathway.

Eque-cel for MS: The FDA has approved the IND application for equecabtagene autoleucel (Eque-cel) for treating multiple sclerosis (MS). Developed by IASO Biotechnology, this chimeric antigen receptor autologous T cell injection showed promising efficacy in six autoimmune diseases in a Chinese trial. MS, affecting 3.07 million people worldwide, is characterized by CNS demyelination and neuronal injury, with Eque-cel offering a new treatment option.

Spravato for TRD: Johnson & Johnson has submitted an sNDA for esketamine (Spravato) as a monotherapy for adults with treatment-resistant depression (TRD). Already approved in combination with an oral antidepressant, esketamine is an NMDA receptor antagonist that rapidly alleviates depressive symptoms. The submission is based on Phase 4 TRD4005 study results, showing rapid improvement in depression scores with a consistent safety profile.

ZW191 Anti-Tumor Agent: The FDA has cleared the IND application for ZW191, a novel antibody-drug conjugate (ADC) targeting folate receptor alpha (FR⍺) in cancers like gynecologic and NSCLC. Developed by Zymeworks, this TOPO1i ADC uses a novel payload, ZD06519, showing robust antitumor activity and a tolerable safety profile in preclinical models. Clinical development of ZW191 is planned to begin in the second half of 2024.

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• The FDA has approved vonoprazan (Voquenza) for treating non-erosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is an oral potassium-competitive acid blocker (PCAB) already approved for erosive esophagitis and Helicobacter pylori infection. PCABs are a new class of medicines that inhibit stomach acid secretion.
• Non-erosive GERD is the most common form of GERD, affecting around 45 million US adults, with about 15 million treated with prescription medication annually. Many patients remain dissatisfied with existing treatments, experiencing symptoms that affect their quality of life.
• The approval of vonoprazan was based on the Phalcon-Nerd-301 study, a Phase 3 trial showing it significantly reduced heartburn episodes and provided more heartburn-free days and nights compared to placebo. The trial included 772 adults with frequent heartburn, demonstrating vonoprazan's effectiveness over placebo.
• The FDA has granted fast track designation to ADI-270 for metastatic or advanced clear cell renal cell carcinoma (ccRCC) in patients who previously received an immune checkpoint inhibitor and a VEGF inhibitor. ADI-270 is a CD70-targeted gamma delta CAR T-cell therapy designed to enhance resilience to the tumor microenvironment.
• A phase 1/2 trial will evaluate ADI-270 in patients with confirmed ccRCC who have been previously treated. The primary endpoints are the incidence of dose-limiting toxicities and the proportion of treatment-emergent adverse effects.
• The FDA has granted Fast Track and Regenerative Medicine Advanced Therapeutic (RMAT) designations to Lomecel-B, an investigational MSC therapy for Alzheimer’s disease (AD). Lomecel-B aims to address neurodegeneration in AD and showed positive results in the CLEAR MIND Phase 2a trial.

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  The FDA has approved blinatumomab (Blincyto) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase. This bispecific T-cell engager (BiTE®) therapy targets CD19 surface antigens on B cells, allowing T cells to recognize and eliminate malignant B cells. The approval was based on the Phase 3 E1910 trial showing improved overall survival with blinatumomab plus chemotherapy compared to chemotherapy alone.

  The FDA has approved roflumilast cream 0.15% (Zorvye) for treating mild to moderate atopic dermatitis (AD) in patients aged 6 years and older. This steroid-free, once-daily topical treatment is a selective, highly potent phosphodiesterase 4 (PDE4) inhibitor designed for long-term disease control. The approval was based on phase 3 studies showing significant improvements in disease clearance, itch reduction, and overall skin condition compared to the vehicle group.

  The FDA has approved a new 6mg single-dose prefilled syringe for faricimab-svoa (Vabysmo), facilitating easier administration for neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Faricimab-svoa is a VEGF and Ang-2 inhibitor, now available in a ready-to-use format. This approval provides an alternative to the existing single-dose vial and is granted to Genentech.

  The FDA is set to decide on OX124, a high-dose naloxone nasal rescue medication designed to reverse opioid overdoses, with the PDUFA date set for July 15, 2024. Developed by Orexo, OX124 offers rapid absorption, high bioavailability, and enhanced stability, addressing the critical need for potent rescue medications due to the high rate of synthetic opioid overdoses. If approved, OX124's launch is anticipated later in 2024.

  The FDA accepted an NDA for vonoprazan (Voquezna) tablets for treating heartburn associated with Non-Erosive gastroesophageal reflux disease (GERD) in adults, with the PDUFA date set for July 19, 2024. Vonoprazan is a potassium-competitive acid blocker (PCAB) offering an alternative to traditional proton pump inhibitors (PPIs). Non-Erosive GERD, affecting 38 million U.S. adults, is characterized by reflux-related symptoms without esophageal mucosal erosions, impacting quality of life with symptoms like heartburn and chest pain.

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- The FDA has approved donanemab (Kisunla) for early symptomatic Alzheimer's disease, making it the third drug in a new class aimed at slowing cognitive decline in early-stage patients. Eli Lilly will make the drug available within weeks following this approval. Donanemab is an anti-amyloid monoclonal antibody that targets amyloid plaques in the brain, a key feature of Alzheimer's. 

- The FDA approval was based on clinical trials showing significant benefits in slowing cognitive decline despite concerns about long-term safety. The advisory committee voted unanimously in favor of the drug, with the FDA granting the approval to Eli Lilly.

- The FDA has approved bedaquiline (Sirturo) for treating multidrug-resistant pulmonary tuberculosis (TB) in adults and children aged five and above. Sirturo initially received accelerated FDA clearance for adults in 2012, with later label expansions for younger patients. Bedaquiline, the first TB drug with a new action mechanism in over 40 years, inhibits mycobacterial ATP synthase, essential for energy production in TB bacteria..

- The FDA is nearing a decision on KarXT, a novel antipsychotic for schizophrenia developed by Karuna Therapeutics. KarXT has shown efficacy in reducing symptom severity in clinical trials, with a favorable side effect profile compared to older antipsychotics. Concerns about insurance coverage exist due to the availability of cheaper generics, but a decision is expected by September 26.

- MDMA-assisted therapy for PTSD, developed by Lykos Therapeutics, has shown significant symptom reduction in clinical trials but faces approval challenges. Despite positive trial results, the FDA advisory panel voted against recommending the drug, citing safety concerns. The FDA's final decision is expected by August 11. 

- Seladelpar, under consideration for primary biliary cholangitis (PBC), is a drug Gilead recently acquired through the purchase of CymaBay. If approved by August 14, it would expand Gilead's liver disease portfolio. Clinical trials have shown seladelpar to be effective in reducing the itching associated with PBC.

- TransCon PTH by Ascendis Pharma is a treatment for hypoparathyroidism, designed to replace parathyroid hormone and help patients achieve normal calcium levels. Despite manufacturing concerns delaying the FDA's decision, the drug has already been approved in Europe and the UK. A final FDA decision is expected by August 14.

 - Afami-cel, a T-cell receptor therapy for synovial sarcoma developed by Adaptimmune Therapeutics, awaits FDA approval by August 4. The therapy targets the MAGE A4 cancer target and is designed as a single-dose treatment. Clinical trial data supporting the application showed efficacy in treating advanced synovial sarcoma.

Do you work for a CME company that needs urgent medical writing assistance? We can help. Visit nascentmc.com - The FDA has approved ensifentrine (Ohtuvayre) as an inhaled maintenance therapy for adults with COPD. Ohtuvayre is the first new mechanism of action for COPD treatment in over two decades, offering anti-inflammatory and bronchodilatory effects to improve lung function and reduce symptoms without the side effects of inhaled corticosteroids. The approval was based on Phase 3 trials showing significant improvement in lung function and fewer exacerbations, granted to Verona Pharma.

- The FDA has approved thiotepa (Tepylute) for breast and ovarian cancer treatment. This new ready-to-dilute formulation saves preparation time and reduces risks, offering benefits like less-invasive treatment options. Breast cancer affects 1 in 8 women, while ovarian cancer has poorer outcomes due to late detection; the approval emphasizes Tepylute's ease of preparation and was granted to Amneal Pharmaceuticals.

- The FDA has approved epcoritamab-bysp (EPKINLY) for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of prior therapy. EPKINLY is the first T-cell engaging bispecific antibody for this indication, providing a new option for patients with limited treatment choices. The approval was based on the EPCORE® NHL-1 clinical trial, showing a high overall response rate, granted to AbbVie.

- The FDA has approved sofpironium topical gel (Sofdra) for treating primary axillary hyperhidrosis in adults and children aged 9 and older. Sofdra, an anticholinergic agent, reduces sweat production and significantly improves quality of life. The approval, based on two phase 3 studies showing significant improvement in sweat production, was granted to Botanix Pharmaceuticals, with expected availability in late 2024.

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- The FDA has approved pitolisant (Wakix) for treating excessive daytime sleepiness (EDS) in pediatric patients with narcolepsy. Pitolisant, a first-in-class treatment targeting the histamine system, was previously approved for adults with narcolepsy. The approval, based on a Phase 3 study, was granted to Harmony Biosciences.

- The FDA has approved crovalimab-akkz (PiaSky) for treating paroxysmal nocturnal hemoglobinuria (PNH) in patients aged 13 and older. Crovalimab, a complement C5 inhibitor, provides sustained complement inhibition through low-dose administration. The approval, based on efficacy in maintaining complement inhibition, was granted to Genentech, Inc.

- The FDA has approved efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Vyvgart Hytrulo, previously approved for generalized myasthenia gravis, demonstrated effectiveness in a two-stage study showing significant improvement in patient outcomes. The approval was granted to Argenx. 

- The FDA has granted fast track designation to IBI343 for treating advanced pancreatic ductal adenocarcinoma (PDAC) that has relapsed or is refractory to one prior therapy. IBI343 is a monoclonal antibody-drug conjugate targeting CLDN18.2-expressing tumor cells. The designation, based on a phase 1 trial showing a 40% overall response rate, was granted to Innovent Biologics.

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• The FDA has approved the 21-valent pneumococcal conjugate vaccine, CAPVAXIVE™ (Merck), for the prevention of invasive disease and pneumonia in adults aged 18 years and older caused by 21 Streptococcus pneumoniae serotypes. Capvaxive includes eight serotypes not covered by other pneumococcal vaccines, addressing approximately 27% of IPD cases in adults aged 50 and older, and 30% in adults aged 65 and older, based on CDC data from 2018-2021. The approval follows an FDA Priority Review and is based on immune responses measured in the Phase 3 STRIDE-3 trial, with continued approval contingent upon verification of clinical benefit in a confirmatory trial. 

• The FDA has approved delandistrogene moxeparvovec-rokl (Elevidys) for Duchenne muscular dystrophy (DMD) in ambulatory individuals aged 4 and older with a confirmed mutation in the DMD gene, as well as granting accelerated approval for non-ambulatory individuals. Elevidys, a one-time intravenous gene therapy, delivers a working copy of the DMD gene to address the muscle degeneration caused by mutations in this gene. The approvals are based on findings from a confirmatory trial that, while not meeting its primary endpoint, showed success in several secondary measures, with the Phase 3 ENVISION study underway to serve as a postmarketing requirement.

• The FDA has approved adagrasib (Krazati) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Adagrasib targets the KRAS G12C mutation, a common driver mutation in several cancers including colorectal cancer, while cetuximab enhances its antitumor activity. The approval was based on findings from the KRYSTAL-1 trial, which demonstrated a confirmed overall response rate (ORR) of 34% and a median duration of response (DOR) of 5.8 months.

• The FDA has approved pembrolizumab (Keytruda) in combination with carboplatin and paclitaxel, followed by pembrolizumab monotherapy, to treat primary advanced or recurrent endometrial carcinoma in adults, marking the third endometrial carcinoma indication for Keytruda in the US. Keytruda enhances the body's immune response against tumor cells by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. The approval is based on results from the phase 3 KEYNOTE-868 clinical trial, which demonstrated significant improvements in progression-free survival for patients treated with Keytruda plus chemotherapy compared to those receiving a placebo with chemotherapy. 

• The FDA has approved risankizumab-rzaa (Skyrizi) for the treatment of moderately to severely active ulcerative colitis in adults, making it the first specific anti–interleukin 23 monoclonal antibody indicated for both ulcerative colitis and moderate to severe Crohn's disease. Risankizumab-rzaa inhibits interleukin-23 (IL-23), a cytokine involved in inflammatory and immune responses, thereby reducing inflammation. The approval is based on data from two phase 3 clinical trials, INSPIRE and COMMAND, which demonstrated the achievement of clinical remission and endoscopic improvement.

• A supplemental Biologics License Application (sBLA) has been submitted for guselkumab (Tremfya) for the treatment of adults with moderately to severely active Crohn's disease. Guselkumab, a fully-human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, was previously approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis. Support for the BLA is based on findings from the Phase 3 GALAXI and GRAVITI clinical trials.

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Adbry for Atopic Dermatitis The FDA has approved tralokinumab-ldrm (Adbry) as a 300 mg single-dose autoinjector for moderate-to-severe atopic dermatitis (AD) in adults, offering a more convenient delivery method. Adbry, which inhibits IL-13, was previously approved for adults in December 2021 and for pediatric patients aged 12 and older in December 2023. The approval was granted to LEO Pharma Inc. 

Augtyro for NTRK Tumors The FDA has approved repotrectinib (Augtyro) for treating solid tumors with NTRK gene fusions in patients aged 12 and older, based on Phase 1/2 trials showing significant response rates in both TKI-naïve and previously treated patients. The approval was granted to Bristol Myers Squibb, with additional clinical data required to confirm safety and efficacy.

Donanemab for Alzheimer's FDA advisors unanimously recommended the approval of donanemab for Alzheimer's disease, emphasizing its efficacy in slowing early-stage disease and manageable risks. Donanemab, targeting amyloid plaques, offers potential advantages over Leqembi with monthly infusions. The FDA decision is expected soon.

Iqirvo for Primary Biliary Cholangitis The FDA granted accelerated approval to elafibranor (Iqirvo) for primary biliary cholangitis (PBC) to be used with ursodeoxycholic acid or as monotherapy. Elafibranor targets PPAR-α and PPAR-δ, with Phase 2 trials showing significant biochemical responses. The approval was granted to GENFIT and Ipsen. 

Retevmo in Thyroid Cancer The FDA granted full approval to selpercatinib (Retevmo) for advanced or metastatic RET fusion–positive thyroid cancer in patients aged 2 years and older, based on the LIBRETTO-001 trial showing high response rates. The approval was granted to Eli Lilly and Company.

OTC Continuous Glucose Monitors The FDA approved Abbott Laboratories' continuous glucose monitoring systems, Libre Rio and Lingo, for over-the-counter use. Libre Rio is for Type 2 diabetes patients not on insulin, while Lingo targets non-diabetic consumers for health improvement. These systems provide real-time glucose monitoring via a smartphone app.

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Visit learnAMAstyle.com for free downloads on medical writing and editing Klisyri for Actinic Keratosis: The FDA has approved tirbanibulin (Klisyri) for treating actinic keratosis (AK) on larger areas of the face or scalp, up to 100 cm². Previously approved for areas up to 25 cm² in December 2020, tirbanibulin is now available in a 350 mg package size for a 5-day topical treatment. Actinic keratosis is the most common pre-cancerous dermatological condition in the US, and this approval was based on a Phase 3 clinical study showing consistent safety and effectiveness for larger treatment areas.

MDMA for PTSD: An FDA advisory panel voted 10-1 against endorsing MDMA for PTSD treatment due to flawed study data, questionable research practices, and significant drug risks. The FDA will make its final decision on August 11, but the panel's negative feedback might influence a denial. This decision could impact the approval and acceptance of other psychedelics like LSD and psilocybin for medical use.

Arexvy for RSV: The FDA has approved the RSV vaccine AREXVY for preventing RSV lower respiratory tract disease in adults aged 50-59 at increased risk. Initially approved in May 2023 for adults aged 60 and older, AREXVY combines a recombinant RSV glycoprotein with an adjuvant. The approval followed a Phase III trial showing the vaccine's immune response and safety in the targeted age group.

Rytelo for MDS: The FDA has approved imetelstat (RYTELO) for treating low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia. Imetelstat, a telomerase inhibitor, demonstrated significant improvements in transfusion independence and hemoglobin levels in the IMerge Phase 3 trial. The approval was granted to Geron Corporation.

Firdapse for LEMS: The FDA has approved an increased dose of amifampridine (Firdapse) from 80 mg to 100 mg for treating Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients over 45 kg. Initially approved in 2018 for adults, and expanded to include children as young as 6 in 2022, the increased dose approval was based on clinical trials showing significant improvements in muscle strength. The approval was granted to Catalyst Pharmaceuticals.

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mRESVIA for Lower Respiratory Tract Disease

The FDA approved mRNA-1345 (mRESVIA) for preventing RSV-caused lower respiratory tract disease in adults 60 and older, based on Phase 3 trial results showing 83.7% efficacy and no serious safety concerns. 

Breyanzi for R/R MCL

The FDA approved lisocabtagene maraleucel (Breyanzi) for treating relapsed or refractory mantle cell lymphoma (MCL) after at least two prior therapies, demonstrating an 85.3% overall response rate in trials.

Sarclisa for ND MM

The FDA accepted the sBLA for isatuximab (Sarclisa) combined with VRd for treating transplant-ineligible newly diagnosed multiple myeloma, showing significant improvement in progression-free survival.

Onyda XR for ADHD

The FDA approved clonidine hydrochloride (Onyda XR) for treating ADHD in pediatric patients aged 6 and older, as a liquid nonstimulant medication with common side effects like somnolence and sedation.

Bkemv for PNH and aHUS

The FDA approved eculizumab-aeeb (Bkemv) as the first interchangeable biosimilar to eculizumab for treating PNH and atypical hemolytic uremic syndrome, requiring meningococcal vaccination prior to use.

Austedo in Huntington’s

The FDA approved a new once-daily tablet option for deutetrabenazine (Austedo XR) for tardive dyskinesia and chorea in Huntington's disease, enhancing treatment flexibility and adherence based on long-term safety and effectiveness data.

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•    Imdelltra for EC-SCLC: The FDA granted accelerated approval for tarlatamab-dlle (Imdelltra) for adults with extensive-stage small cell lung cancer (ES-SCLC) who progressed after platinum-based chemotherapy. Small cell lung cancer, accounting for 10-15% of all lung cancers, is aggressive with a median survival of 12 months post-therapy. Imdelltra, a first-in-class BiTE therapy targeting DLL3, showed a 40% objective response rate and a median overall survival of 14.3 months in the phase 2 DeLLphi-301 trial.

•    Breyanzi for R/R LL: The FDA granted accelerated approval for lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory follicular lymphoma after two or more systemic therapies. This CAR T-cell therapy, already approved for other B-cell malignancies, genetically modifies T cells to target tumor antigens. In the TRANSCEND FL trial, Breyanzi achieved a 95.7% overall response rate in 94 patients, with the median response duration not reached after 16.8 months.

•    SNB-101 for SCLC: The FDA granted fast-track designation to SNB-101 for small cell lung cancer (SCLC). SNB-101, a polymer nanoparticle formulation of the antineoplastic agent SN-38, enhances lung-specific delivery and efficacy. Early data indicates improved tolerability and efficacy, with global phase 2 trials planned for various solid tumors including colon and gastric cancers, led by SN BioScience.

•    Upstaza for AADC Deficiency: The FDA accepted the Biologics License Application for eladocagene exuparvovec (Upstaza), a gene therapy for aromatic L–amino acid decarboxylase (AADC) deficiency, with a Priority Review and a target date of November 13, 2024. Upstaza delivers the human DDC gene to the putamen, increasing AADC enzyme levels to restore dopamine production, showing significant neurological improvements in clinical trials. Approval was granted to PTC Therapeutics, Inc.

•    Altuviiio for Hemophilia A Label Update: The FDA approved an updated label for Altuviiio (antihemophilic factor, recombinant), including phase 3 XTEND-Kids trial results. This high-sustained factor VIII replacement therapy, initially approved in 2023, offers prolonged bleed protection for pediatric patients under 12 years with hemophilia A. The updated label confirms Altuviiio’s safety and effectiveness for both routine and on-demand treatment.

•    Self-Collected Sample for Cervical Cancer Screening: The FDA approved the BD Onclarity™ HPV Assay for self-collected vaginal specimens for HPV testing when traditional cervical samples are not available. This assay, identifying six HPV strains, enhances screening access, especially for underserved populations with higher cervical cancer rates. Approval was granted to Becton Dickinson.

•    Clinolipid Parenteral Nutrition: The FDA approved Clinolipid (Lipid Injectable Emulsion) for pediatric patients, including preterm and term neonates. Clinolipid, a mixed oil lipid emulsion providing essential fatty acids and calories, has been available for adults since 2019 and is now approved for all ages. Approval was granted to Baxter International Inc.