(Reuters) -Biogen said on Thursday that the European Commission has granted marketing authorization under exceptional circumstances for its amyotrophic lateral sclerosis (ALS) drug Qalsody.
The drug is the first treatment approved in the European Union (EU) to target a genetic cause of ALS, the company said.
The approval is based on a 108-patient trial that showed Qalsody reduced levels of a neurofilament protein that scientists believe is tied with the disease’s progression.
The drug targets a rare form of ALS caused by a genetic mutation that leads to the accumulation of toxic levels of the SOD1 protein.
Through the Biogen early access program, about 330 ALS patients with the SOD1 mutation have received the drug across 18 EU countries, the company said.
(Reporting by Sneha S K in Bengaluru; Editing by Alan Barona)
Comments