French healthcare company Sanofi SA (Euronext Paris:SAN) (NASDAQ:SNY) announced on Tuesday that the European Commission has granted marketing authorisation for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease.

Pompe disease is a rare, progressive and debilitating muscle disorder. If left untreated, infantile-onset Pompe disease (IOPD) can lead to heart failure and death within the first year of life, while people with late-onset Pompe disease (LOPD) may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility as the disease progresses.

Nexviadyme is the first newly approved medicine for Pompe disease in Europe since 2006, when the European Commission authorised the marketing of Myozyme (alglucosidase alfa).

The treatment is approved in multiple markets around the world for the treatment of certain people living with Pompe disease, including the European Union, the United States, Japan, Canada, Switzerland, Australia, Brazil, Taiwan and the United Arab Emirates. Outside of Europe, it is marketed under the brand name Nexviazyme.