European Commission grants marketing approval to Biogen's ALS drug
(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 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.
In February, Europe's medicines regulator recommended granting marketing authorization to Qalsody.
The marketing authorization is granted under exceptional circumstances when the benefit/risk assessment of a treatment is positive but it is unlikely that comprehensive data can be obtained due to the rarity of the disease.
Europe's medicines regulator recommended Qalsody's designation as an orphan medicinal product be maintained, Biogen said in its statement.
Qalsody, received accelerated approval in the United States in April last year and brought in $5.9 million in revenue for Biogen in 2023.
Biogen and Ionis Pharmaceuticals said, earlier this month, that they will terminate the development of their experimental ALS treatment after it failed to show improvement in patients in an early-to-mid stage study.
(Reporting by Sneha S K in Bengaluru; Editing by Alan Barona)
