FDA to look at drugs for HFpEF; Covid-19 vaccine, round 2

Lynne Peterson is the Senior Writer for Trends-in-Medicine.

Here is the medical news to watch for December 14-20, 2020.

Cardiology: The FDA’s Cardiovascular and Renal Drugs Advisory Committee is holding a two-day virtual meeting on expanded approval of two drugs to treat heart failure with preserved ejection fraction (HFpEF):

  • On December 15: Novartis’ Entresto (sacubitril + valsartan).
  • On December 16: Pfizer’s Aldactone (spironolactone).

Covid-19: On December 17, the FDA’s Vaccines and Related Biological Products Advisory Committee will consider whether the FDA should issue an emergency use authorization (EUA) for Moderna’s mRNA-1273, a two-dose mRNA Covid-19 vaccine. The panel meeting will be webcast by the FDA and will be available on YouTube and Twitter.

Gene therapy: The virtual Cell Therapy Analytical Development Summit will take place December 15-17. This meeting on cell therapy analytics focuses on how to robustly validate assays and advance the characterization of cell immunotherapy analytics to ensure safe, effective, and quality cell therapy products.

Nephrology: The FDA is expected to make a decision by December 20 on an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for anemia of chronic kidney disease, FibroGen and AstraZeneca’s roxadustat.

Oncology:

  • The International Symposium on Pediatric Neuro-Oncology (ISPNO) is continuing through December 16 as a hybrid meeting – onsite in Karuizawa, Japan, and virtual.
  • The FDA is expected to make a decision by December 18 on MacroGenics’ margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2, for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy.
  • The FDA is expected to make a decision by December 19 on Amgen and AbbVie/Allergan’s ABP-798, a biosimilar of rituximab (Roche’s Rituxan), to treat several diseases, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis, and microscopic polyangiitis with glucocorticoids.
  • The FDA is expected to make a decision by December 20 on Myovant Sciences’ Relumina (relugolix), an oral gonadotropin-releasing hormone receptor antagonist for treating advanced prostate cancer.

Regulatory

  • On December 16 the FDA is hosting another in its series of virtual town halls on coronavirus test development and validation.
  • The FDA is holding a webcast on December 16 to discuss diversity in clinical trials.

Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine

Cat ID: 914

Topic ID: 74,914,730,914,22,25,467,935,190,127,192,151,725

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