Biogen Inc on Thursday said its drug, Spinraza, had secured European Union approval to treat spinal muscular atrophy (SMA), a leading genetic cause of death in infants.
It is the first European Commission-approved medicine for use across the full range and severity of the devastating disease that affects about one in 10,000 live births.
The availability of the drug in the EU will vary by country, depending on access, the company said.
The drug, known chemically as nusinersen, was discovered by Ionis Pharmaceuticals and licensed to Biogen.
Based on the European Commission approval, Ionis will receive a $50 million milestone payment. Ionis is also eligible to receive royalties on global sales of Spinraza.
The drug was first approved by the U.S. Food and Drug Administration in December. Priced at $125,000 per injection in the first year of use in the United States, the treatment generated sales of $47 million in the first quarter.
SMA is caused by deficiency of a protein called smn in the spinal motor neurons. It leads to severe and progressive muscular atrophy and weakness, including in muscles needed for breathing and swallowing. Spinraza, which is injected into the spinal fluid, increases the levels of the deficient protein.
(Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Arun Koyyur)