The European Commission (EC) has approved Sanofi’s (SNY) first line oral therapy, Cerdelga, for the treatment of certain adults suffering from Gaucher disease type I. The company said that adults who metabolize Cerdelga more rapidly or at an undetermined rate will not be eligible for Cerdelga treatment.
The EU approval of Cerdelga did not come as a surprise as, in Nov 2014, the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion on the approval of the drug for the treatment of certain adults suffering from Gaucher disease type I.
The drug is approved to treat those patients suffering from Gaucher disease type I who are CYP2D6 poor metabolizers, intermediate metabolizers or extensive metabolizers. Cerdelga is expected to be launched in the EU early in 2015 and over the next few years.
Cerdelga is already approved in the U.S. for the treatment of Gaucher disease type I. The drug is under regulatory review in several other countries as well. Sanofi believes that Cerdelga has the potential to boost the company’s Gaucher franchise, which also has Cerezyme, to over €1 billion. Sanofi recorded Cerezyme sales of €518 million for the first nine months of 2014.
Shire’s (SHPG) Vpriv is another Gaucher disease product approved in the market.
Sanofi carries a Zacks Rank #4 (Sell). Some better-ranked companies in the health care space are Alexion Pharmaceuticals, Inc. (ALXN) and AbbVie Inc. (ABBV). While Alexion holds a Zacks Rank #1 (Strong Buy), AbbVie carries a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment