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The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
On June 24, 2016, the European Medicines Agency (EMA) announced it was recommending the suspension of Riluzole Alkem, a treatment for amyotrophic lateral sclerosis (ALS), because of flawed studies performed by Alkem Laboratories’ site in Taloja, India. An inspection of the facility in March 2015 by German and Dutch authorities discovered misrepresentation of data during trials performed in 2013 and 2014 at the Taloja site. EMA states that the company’s quality management system is in doubt and, therefore, the results of bioequivalence studies conducted between March 2013 and March 2015 cannot be relied upon.
While EMA’s Committee for Medicinal Products for Human Use (CHMP) says there is no evidence the drug is harmful or not effective, the study results are not acceptable for market authorization in the European Union. CHMP recommends drugs “authorized or being evaluated on the basis of these studies be suspended or refused authorization unless alternative data are available from other sources.”
As well as the suspension of the authorization of Riluzole Alkem, CHMP recommends that other products currently under evaluation, including Ibuprofen Orion, Cefuroxime Ingen Pharma, Cefuroxime Alkem, and Cefuroxime Krka, not be authorized until alternative studies are provided. The CHMP’s recommendations will be sent to the European Commission for a legally binding decision throughout the European Union.