FDA approves once-a-year multiple sclerosis drug by Genzyme with warnings

Genzyme's once-a-year drug to treat multiple sclerosis hasbeen approved with a boxed warning noting a risk of serious side effects. The approval comes more than 10 months after the drug was rejected by U.S. regulators. The rejection last December came about because the U.S. Food and Drug Administration prefers trials in which patients are blinded to which drug they are taking. Genzyme's trials tested more than 1,600 patients, comparing Lemtrada to EMD Serono's drug, Rebif. Since the two drugs have…
Source: bizjournals.com Health Care:Hospitals headlines - Category: Hospital Management Authors: Source Type: news