Sanofi SA (ADR) (NYSE:SNY)’s Priority Review And New Drug Application
Sanofi SA (ADR) (NYSE:SNY) is a Paris, France based major drug manufacturer that operates in pharmaceuticals, human vaccines, and animal health segments. Its subsidiary, Genzyme’s marketing authorization application for eliglustat in the European Union was validate in late October by the European Medicines Agency. Eliglustat is a development stage pharmaceutical for adult patients with Gaucher disease type 1 and is currently being tested for its oral dosage.
This week Sanofi SA (ADR) (NYSE:SNY) announced that Genzyme has been granted a six-month Priority Review designation by the U.S. Food and Drug Administration. This designation has been granted to Genzyme’s New Drug Application for Cerdelga which contains eliglustat as an active ingredient.
Genzyme’s eliglustat related clinical development program involves around 400 patients from 29 countries, making it the largest clinical program for Gaucher disease. The success of this program would allow a broader range of treatment options for Gaucher disease type 1.
Over thirty years, Genzyme has pioneered in the development of transformative therapies and has successfully evolved from a start-up to the world’s leading biotech companies. This Boston, Massachusetts based company was acquired by Sanofi SA (ADR) (NYSE:SNY) in 2011. Genzyme has developed core expertize in rare genetic diseases, LSDs or Lysosomal Storage Disorders as well as thyroid cancer and multiple sclerosis.
FDA’s Priority Review designation means the NDA will be processed within 6 month time frame against 10 month time frame for Standard Review. Recently FDA has granted Priority Review designation to Durata Therapeutics Inc. (NASDAQ:DRTX)’s NDA for Dalvance which is indicated for treating acute bacterial skin and skin structure infections.
Merck & Co., Inc. (NYSE:MRK)’s NOXAFIL that contains posaconazole had also been granted priority review recently in November 2013. The drug is an antifungal agent and was investigated for its intravenous solution formulation.