According to Forbes “While the FDA is continuing to carry out reviews funded by fiscal year (FY) 2018 Prescription Drug User Fee Act user fees, including the review and approval of new drugs and biologics funded by carryover user fee balances, the agency is not accepting FY 2019 user fees until funding appropriations have been authorized, i.e., the political impasse has been resolved. Consequently, the FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees and is not reviewing applications for new drugs and biologics submitted during the shutdown period, except for emergency INDs and BLAs. The FDA is also not reviewing medical device applications submitted during the lapse period. And, the FDA is curtailing work on regulatory guidance documents pertaining to medical devices, drugs, and biologics.”
FDA Actions in spite of the shutdown…
The FDA has accepted two NDAs from Pfizer on 1/14/19 for tafamidis. Tafamidis meglumine was granted a priority review with a July 2019 PDUFA date and the free acid of tafamidis will receive a standard review with a November 2019 PDUFA date. Tafamidis meglumine requires four 20 mg capsules for a dose, while 61 mg of the free acid will be available as a single capsule.
The FDA granted serlopitant Breakthrough Therapy status in January 2019.
The FDA Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 to recommend approval of romosozumab on 1/17/2019, but also recommended a boxed warning for cardiovascular safety.
The FDA rejected sacituzumab govitecan on 1/17/2019 due to problems with manufacturing the drug.
Eisai and Purdue Pharma submitted an NDA for lemborexant in January 2019.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee had a split decision (8-8) on sotagliflozin on whether to recommend approval of the drug as an add-on to insulin therapy in patients with type 1 diabetes on 1/17/2019. Some members of the committee expressed concern regarding the increased risk for diabetic ketoacidosis with the drug.
In a 52-week open label extension of a Phase III idalopirdine trial, no beneficial effects were seen. Idalopirdine was safe and well tolerated when added to donepezil, and memantine.
In a 2-year, 86 patient, Phase II, open label, single arm, Chinese trial, treatment with zanubrutinib resulted in an overall response rate of 83.5% with a progression free survival in 82% of patients with Mantle Cell Lymphoma.
An evaluation of data from the STRATOS 1 and 2 trials suggested there was no risk of severe hypersensitivity or anaphylactic reactions with tralokinumab.
In a 138-patient trial, treatment with udenafil decreases postmicturition dribbling in healthy men with a mean age of 57.6 years.
Phase III data identified an increased risk for stroke that caused Merck to discontinue development of odanacatib.
In a 6-month, 38 patient Phase I/II trial, treatment with voxelotor increased hemoglobin and reduced hemolysis in patients with sickle cell disease.
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