Sanofi hoped to increase its share of the multiple sclerosis drug market with Lemtrada, which received the approval of European regulators earlier this year. The multiple sclerosis drug has also won clearance from Canadian and Australian regulators. In its ruling, the FDA said that the multiple sclerosis drug required more clinical trials contrasting its performance with another treatment, Bloomberg noted.
The market for drugs that treat multiple sclerosis generates $20 billion in annual revenue. Sanofi acquired Lemtrada through its 2011 purchase of Genzyme.
An analyst at Bryan Garnier warned that Lemtrada’s rejection could have significant consequences, potentially delaying the entrance of Sanofi’s drug into the multiple sclerosis market by up to three years.
Shares of SNY stock fell almost 1% in pre-market trading on Monday.