Jayendra Dabhi
Dec 30, 2017
Novel Drug Approved in December 2017
- Sanofi's Admelog (Short Acting Insulin) approved as a "follow-on product" on December 11, 2017 by US FDA's 505(b)(2) pathway.
- On December 12, 2017 GSK's Nucala (Mepolizumab) became the first FDA approved therapy specifically to treat Eosinophilic Granulomatosis with Polyangiitis. (A rare disease, formerly known as the Churg Strauss Syndrome)
- The FDA approved Spark Therapeutics Inc's Luxturna (Voretigene neparvovec-rzyl), a novel gene therapy, to treat patients with a rare form of inherited vision loss on December 19, 2017. Luxturna is the first gene therapy approved in the U.S. to target a disease caused by mutations in a specific gene. (First in Class!)
- Giapreza (Angiotensin II) of La Jolla Pharmaceutical approved to increase blood pressure in adults with septic or other distributive shock received thumbs up from the FDA on December 21, 2017.