Nine Biotechs Await Their FDA Decisions in December
With 2017 coming to a close, the biopharma industry and the US Food and Drug Administration (FDA) are preparing to face a very busy time.
So far, 40 drugs have been approved, with the record being in 2015, when 46 drugs were approved. Currently, nine companies are awaiting decisions this month, writes BioSpace.
The first being Amgen. They have been awaiting a decision on their supplement Biologics License Application (sBLA) of Repatha to include the drug’s ability to cut the risk of major adverse cardiovascular events. Initially the drug was first approved to treat high cholesterol, but additional studies were required to prove that it actually resulted in fewer heart attacks, angina, stroke or related events.
In addition, Mylan is hoping for FDA approval for its BLA for MYL-14010, a biosimilar for Roche’s Herceptin for breast cancer. After receiving a unanimous thumbs-up from the FDA, the PDUFA date for the drug is 3 December.
Novo Nordisk who produced a once-weekly Semaglutide for type 2 diabetes on 5 December, is also expecting FDA approval. When it was pitched up against a trial of Trulicity, Semaglutide had a better reduction in HbA1c and body weight compared to once-weekly Trulicity.
Similarly, Aclaris Therapeutics will get a decision from the FDA for its New Drug Application for A-101 40% topical solution for seborrheic keratosis by 24 December. The compound is designed to penetrate the seborrheic keratosis (SK) leison and cause oxidative damage, which can cause the SK cells to shed.
Pfizer, alongside Agile Therapuetics, Valeant Pharmaceuticals International, and Aeterna Zentaris has also found itself in the FDA approval process. Their supplemental new drug application (sNDA) for Xelijanz 5 mg and Xelijanz XR 11mg, is for adults with active psoriatic arthritis. It is already approved for adults with Ph+ CML resistant to or intolerant to previous therapy.
Lastly, Pfizer in addition to Merck, have three New Drug Applications for Ertugliflozin for adults with Type 2 diabetes. They are currently seeking FDA approval, as well as fixed dose combinations with Merck’s Januvia and Metformin. In clinical trials, the drug has shown to significantly decrease in A1C over two to three months when dosed with Metformin or in an initial co-dosing with Januvia.