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.