This column summarizes newly approved drugs and new indications and patient population for already approved drugs from June to September 2017. This includes New Drug Applications (NDAs), Biologics Licensing Applications (BLAs) and Biosimilar applications. FDA granted approvals to 61 applications in these four months.
Thirty-eight (62.3%) approvals were for small molecules, while the remaining 23 (37.7%) were for large molecules. Thirteen of the 23 (56.5%) large molecules were predominantly for cancer treatment. Amgen and Bristol-Myers Squibb received a total of three approvals each in these four months. Genentech, GlaxoSmithKline, Janssen, AstraZeneca, Gilead Sciences, Wyeth Pharma and Ipsen Biopharma Ltd. were granted two approvals each in this period. The types of dosage forms approved were – injections: 35 (57.3%), tablets and capsules: 20 (32.8%), oral powders and granules 2 (3.3%), spray and inhalers, oral solution and intrauterine device 1 (1.6%).
Following are the noteworthy approvals in these four months. On June 16, the FDA approved the use of Darzalex® (Daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma. This approval offers another alternative to patients with multiple myeloma who haven't seen lasting effects from other types of treatment. The approval was based on data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma.
On July 26, Eisai Inc. received FDA approval for a supplemental New Drug Application for its antiepileptic drug (AED) Fycompa® (Perampanel) as monotherapy use for the treatment of partial-onset seizures in patients with epilepsy 12 years of age and older. The regulatory approval was based on extrapolation of efficacy and safety of Fycompa® approved as adjunctive therapy for the treatment of partial-onset seizures to its use as monotherapy for the treatment of partial-onset seizures. Fycompa® is the first AED to be approved as monotherapy for partial-onset seizures according to this regulatory pathway.
There are several spironolactone tablets available in the market. CaroSpir® is the first liquid formulation of spironolactone which provides a stable and consistent treatment option for adult patients who have difficulty swallowing. The company received a US patent # 9757394 for the aqueous formulation on September 12, 2017.