This column summarizes newly approved drugs, biologics, new indications and patient populations for already approved drugs from October to December 2017. This includes New Drug Applications (NDAs), Biologics Licensing Applications (BLAs) and Biosimilar applications. FDA granted approvals to 61 applications in these three months.
Forty-three (70.5%) small molecules and eighteen (29.5%) large molecules got approved from October 2017 to December 2017. The highest number of drugs/biologics approved (15 out of 61 or 24.5%), belonged to cancer treatment while the treatment of inflammatory, infectious, cardiovascular, diabetes and ocular diseases had five drug approvals each. With two efficacy supplemental NDA (sNDA) and four BLA approvals, Genentech, Inc. received a total of six approvals in the last three months of 2017. Merck and Pfizer also received five approvals each. One of Pfizer’s five approvals is Ixifi (Infliximab-qbtx). Ixifi is a Tumor Necrosis Factor (TNF) blocker and it is indicated for Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Plaque Psoriasis. It is a biosimilar to Janssen’s Remicade. The types of dosage forms approved were – injections: 28 (44.4%), tablets and capsules: 22 (34.9%), ophthalmic formulations: 5 (7.9%), oral solutions: 3 (4.8%), creams: 2 (3.2%) and inhalation formulations, sinus implant and topical solutions: 1 (1.6%) each. Varubi (Rolapitant) and Prevymis (Letermovir) were approved as Tablets and Injections formulations.
Following are the two noteworthy approvals in these three months: After the 505(b)(1) NDA approval on November 13, 2017, Otsuka Pharmaceutical’s Abilify MyCite kit became the first drug in the U.S. with a digital ingestion tracking system. The tablet is embedded with a tiny sensor the size of a sand grain, which tracks the date and time of the ingestion of the tablet. Abilify MyCite (aripiprazole) is a tablet formulation of atypical antipsychotic aripiprazole for treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.
On November 20, 2017, Kaleo, Inc. was granted approval to their supplemental NDA (sNDA) of Auvi-Q autoinjector under section 505(b) (2) of the FD&C Act. Auvi-Q (epinephrine injection, USP), is the first and only epinephrine auto-injector (EAI) for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children. It comes with a voice prompt system to guide step-by-step delivery process instructions and an automatic self-retracting needle following the administration of Auvi-Q.