Lynne Peterson is the Senior Writer for Trends-in-Medicine.
Here is the medical news to watch for December 20, 2021-January 2, 2022.
Have a Merry, Merry Christmas and a very Happy New Year!
Cardiology: The FDA is expected to make a decision by January 1, 2022, on Alnylam Pharmaceuticals and Novartis’ Leqvio (inclisiran), a twice-a-year small interfering RNA (siRNA) therapy that inhibits PCSK9 to lower cholesterol. Remember, the FDA rejected Leqvio in December 2020 over third-party manufacturing issues, but a new drug application (NDA) was refiled in July 2021.
Endocrinology: The FDA is expected to make a decision by January 1, 2022, on a new treatment for Cushing’s syndrome—Strongbridge Biopharma’s Recorlev (levoketoconazole), a cortisol synthesis inhibitor.
Hematology: The FDA is expected to make a decision by December 25 on a supplemental new drug application (sNDA) for Global Blood Therapeutics’ Oxbryta (voxelotor), a hemoglobin S polymerization inhibitor, to expand use to include children age 4-11 with sickle cell disease. The FDA is also expected to make a decision the same day on an NDA for a new dispersible tablet formulation of Oxbryta.
Neurology: The FDA is expected to make a decision by December 23 on a buccal film formulation of diazepam (Aquestive Therapeutics’ Libervant) to manage seizure clusters. The FDA rejected Libervant in September 2020, but additional information was provided to the FDA, and the NDA was resubmitted.
Regulatory: The FDA has no webinars, webcasts, or advisory committee meetings scheduled during this 2-week period.
Lynne Peterson, Contributing Writer, Senior Writer for Trends-in-Medicine
Cat ID: 725
Topic ID: 88,725,730,914,187,118,130,192,725,925
