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Genzyme investigational Phase III MS drug meets co-primary endpoints

Genzyme has reported positive Phase III results of Alemtuzumab (Lemtrada) to treat multiple sclerosis (MS).

The randomized trial was designed to assess whether the investigational alemtuzumab could achieve efficacy and safety improvements over the approved interferon beta-1a (Rebif).

The trial enrolled patients who have experienced at least two relapses within the two years prior therapy .

The trial met two co-primary endpoints including a reduction in relapse rate and six months sustained accumulation of disability (SAD).

Genzyme president and CEO David Meeker said based on these positive results, they are on track to submit Lemtrada for review to US and EU regulatory authorities in the first quarter of 2012.