This column summarizes newly approved drugs and new indications for already approved drugs from February to May 2017. This includes New Drug Applications (NDAs) for small molecules, Biologics Licensing Applications (BLAs), Medical devices and Biosimilar applications. FDA approved 52 applications in these four months.
Twenty nine (55.8%) approvals were for small molecules, while the remaining 23 approvals (44.2%) were for large molecules. Ten of the total 23 large molecules (43.5%) were predominantly for cancer treatment. Genentech, Inc. received a total of four BLA approvals in these four months. Merck Sharp Dohme also received 4 approvals out of which, three were BLAs for the new indications of Keytruda and one was for Isentress HD as an efficacy supplement in the treatment of HIV. Novartis and Astra Zeneca were granted three approvals in this period. Five out of 52 (9.6%) of new drug approvals were a 505(b)(2) applications. Seven out of 52 (13.5%) approvals were granted under Accelerated approval pathway and Orphan drug designation. Dupixent, a Regeneron Pharmaceuticals drug, was approved for Atopic dermatitis under Breakthrough Therapy designation. The types of dosage forms approved were – Injections: 23 (44.2%), Tablets and capsules: 22 (42.3%), Spray and inhalers: 2 (3.8%), and Oral suspension, granules, oral solution, ophthalmic solution and injectable gel were one (1.9%) each.
Emflaza (deflazacort) Tablets and Oral suspension is the first FDA approval of any corticosteroid to treat Duchenne Muscular Dystrophy (DMD). DMD is a rare genetic disorder that causes progressive muscle deterioration and weakness. The FDA granted this application fast track designation and priority review. The drug also received orphan drug designation.
Allergan developed next-generation Hyaluronic Acid fillers designed for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21 in the form of an injectable gel, a class III medical device, and was granted a Premarket approval under the trade name Juvéderm Vollure XC.