- The FDA will carry out a priority review of Sanofi's (SNY) Eliglustat pill for Gaucher disease, a rare genetic disorder in which sufferers are deficient in an enzyme that breaks down a certain type of fat. That can lead to potentially fatal organ and bone problems.
- The FDA will now rule on whether to approve Eliglustat within six months instead of ten.
- The agency's move comes after the European Medicines Agency validated a marketing authorization application for Eliglustat in October.
- Analysts have forecast that Eliglustat, which would become the first oral treatment for Gaucher's disease, could generate annual sales of $517M by 2018. Other therapies include Sanofi's Cerezyme injection, Shire's (SHPG) Vpriv and Pfizer's (PFE) Elelyso.
- Sanofi shares are +1% in Paris.
FDA grants priority review to Sanofi's Gaucher drug
Dec 11 2013, 07:21 ET