EMA gives a positive opinion on ALS drug
Thursday 16 February 2012
On 16 February, the European Medicines Agency (EMA) issued a positive opinion on a drug for the treatment of amyotrophic lateral sclerosis (ALS).
The EMA's Committee for Medicinal Products for Human Use (CHMP), on the basis of quality, safety and efficacy data submitted for the reference product Rilutek, considers there to be a favourable benefit-to-risk balance for Riluzole Zentiva and therefore recommends the granting of the marketing authorisation.
The EMA's opinion has been forwarded to the European Commission, which is responsible for granting the final marketing authorisation.