Jayendra Dabhi
Dec 30, 2017

Novel Drug Approved in December 2017

  1. Sanofi's Admelog (Short Acting Insulin) approved as a "follow-on product" on December 11, 2017 by US FDA's 505(b)(2) pathway.
  2. 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)
  3. 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!)
  4. 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.