(Reuters) – Europe’s medicines regulator said on Friday that it has recommended granting a marketing authorization for Biogen’s drug for a type of neurological disease known as amyotrophic lateral sclerosis (ALS).
The drug, Qalsody, got an accelerated approved in the United States in April last year, based on data that showed it reduced levels of a protein that is believed to be an indicator of nerve cell degeneration.
ALS is a rare neurological disease that can affect nerve cells in the brain and spinal cord responsible for muscle movements, leading to progressive paralysis and death.
The European Medicines Agency (EMA) said there is a large unmet medical need for effective therapies that preserve muscle function and prolong the life of patients with ALS.
Biogen will have to submit data post-authorisation to characterise the long-term efficacy and safety of Qalsody, according to the EMA.
(Reporting by Puyaan Singh and Christy Santhosh in Bengaluru; Editing by Dhanya Ann Thoppil and Shounak Dasgupta)
