Genzyme's new Gaucher drug gains approval in Japan

Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Cerdelga (eliglustat), the only oral therapy for the treatment of adults with Gaucher disease type 1 in Japan, from Genzyme, the biotech subsidiary of French pharma major Sanofi (Euronext: SAN).

Cerdelga was approved by the US Food and Drug Administration in August 2014, the European Commission in January 2015, and the Australian Therapeutics Goods Administration in February 2015.

Cerdelga adds to Genzyme’s rare disease drug portfolio, and will complement Cerezyme (imiglucerase for injection), the standard of care for patients with Gaucher disease type 1, which is administered through intravenous infusions. Sales of Cerdelga were abour4 million euros ($4.36 million) in the fourth quarter of 2014.