- The FDA has rejected Sanofi's (SNY) Lemtrada treatment for multiple sclerosis, saying that the French company hasn't submitted enough evidence to show that the benefits of the drug outweigh its serious side effects.
- The decision is not a total surprise, as FDA staff had already raised safety concerns and questioned the adequacy of clinical trials.
- However, the agency did leave open the possibility that Lemtrada could eventually be approved, but Sanofi would need to conduct more testing first.
- The FDA's rejection comes despite authorization from the EU and Canada, and after the U.K.'s NICE authority asked for more information by January 9.
- Contingent value right tied to Lemtrada: GCVRZ (PR)
FDA rejects Sanofi multiple sclerosis drug
Dec 30 2013, 02:11 ET