Biogen/ Ionis ALS therapy undergoes European review
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Biogen (NASDAQ:BIIB) announced Monday that the European Medicines Agency (EMA) accepted its marketing application for tofersen, an experimental therapy the company developed with Ionis Pharmaceuticals (NASDAQ:IONS) for amyotrophic lateral sclerosis (ALS).
With the Marketing Authorization Application (MAA), Biogen (BIIB) seeks EU approval of the antisense drug in the treatment of superoxide dismutase 1 (SOD1) ALS, a neurodegenerative disease caused by the mutation in the SOD1 gene.

There are no approved therapies to treat SOD1-ALS, a condition that affects less than 1,000 people in Europe.
The MAA includes data from the Phase 3 VALOR study and 12-month integrated results from VALOR and the OLE study, published in The New England Journal of Medicine in September.
âRegulatory submissions in the U.S. and now EU represent an important step in our efforts to bring the first genetically-targeted treatment for SOD1-ALS to the ALS community as quickly as possible,â Priya Singhal Biogenâs (BIIB) Interim Head of R&D.

In October, the company announced that the FDA extended the review period for tofersen by three months to April 25, 2023.