FDA expands approval of Genzyme's Lumizyme to treat Pompe disease

The US Food and Drug Administration on Friday approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than eight years of age. The drug is produced and marketed by Genzyme, the USA-based biotech subsidiary of French drug major Sanofi (Euronext: SAN).

In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated, said the FDA. Pompe disease is a rare genetic disorder and occurs in an estimated 1 in every 40,000 to 300,000 births.

First approved by the FDA in 2010