Sanofi's (SNY) Cerdelga FDA Approved for Gaucher Disease

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Sanofi (SNY) announced that the FDA has approved Cerdelga for the treatment of Gaucher disease type 1. However, the drug is not indicated for adults suffering from Gaucher disease type 1 who metabolize Cerdelga very quickly or at an undetermined rate, as detected by an FDA approved test. The company is planning to launch Cerdelga in a month.

Approval of Cerdelga marks the approval of the only first-line oral therapy for adult Gaucher disease type 1 patients. Currently, intravenous enzyme replacement therapies are the standard of care for Gaucher disease. Currently approved drugs for the treatment of Gaucher disease include Sanofi’s Cerezyme and Shire’s (SHPG) Vpriv among others.

Thus, Cerdelga will provide Gaucher disease patients with an alternative and more convenient treatment option. As per the company press release, globally Gaucher disease affects fewer than 10,000 people with type 1 being the most common form of the disease.

The FDA approved Cerdelga on the basis of efficacy data from two positive phase III studies.

Our Take

We are pleased with the approval of Cerdelga. We believe that the drug will complement Sanofi’s portfolio which includes Gaucher disease product Cerezyme. Cerezyme generated revenues of €343 million in the first half of 2014, up 7.9% from the year-ago period.

Sanofi presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan (AGN) and AstraZeneca (AZN). While Allergan carries a Zacks Rank #1 (Strong Buy), AstraZeneca is a Zacks Rank #2 (Buy) stock.

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