In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from September 11, 2023 – September 15, 2023.  Please check back every Monday morning so that you can stay up to date. 

See more details summaries and links to prescribing information at nascentmc.com/podcast

Here are the highlights:

• Ojjaara for Anemia in Myelofibrosis: FDA approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis in adults with anemia. This drug is unique as it serves both newly diagnosed and previously treated patients, addressing anemia, constitutional symptoms, and splenomegaly. Approval was based on the MOMENTUM phase 3 trial results.

• Resmetirom for NASH: FDA granted priority review for resmetirom, aiming to treat non-alcoholic steatohepatitis (NASH). Madrigal, its manufacturer, seeks approval via the FDA’s accelerated pathway. Resmetirom is evaluated in four phase 3 trials, including MAESTRO-NASH. The decision is set for March 14, 2024.

• Updated COVID-19 Vaccines: FDA approved updated vaccines for the coming season targeting the omicron descendant XBB.1.5. While older vaccines targeted earlier strains, these new shots might provide protection against prevalent related strains. Pfizer, Moderna, and Novavax are manufacturing the vaccines.

• Phenylephrine Lack of Efficacy: An FDA panel unanimously found phenylephrine, present in OTC decongestants like Sudafed and Dayquil, ineffective for its intended use. If the FDA agrees, over 250 products containing phenylephrine might be withdrawn from the market. This decision does not affect nasal preparations.

• Patisiran for ATTR-CM: The FDA’s advisory committee voted that the benefits of patisiran surpass its risks for treating cardiomyopathy induced by transthyretin amyloidosis (ATTR-CM). Although the drug showed small effects compared to placebo in the Phase III APOLLO-B study, it met primary and secondary endpoints. The FDA's decision will be made on or before Oct. 8, 2023.

Intro and outro music

Garden Of Love by Pk jazz Collective