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What the CHMP Just Recommended for Alkem’s Riluzole Alkem

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Suspension of Riluzole Alkem  

The EMA’s (European Medicines Agency) CHMP (Committee for Medicinal Products for Human Use) recommended the suspension of Alkem’s Riluzole Alkem on June 24, 2016. Riluzole Alkem is the generic version of Sanofi’s (SNY) Rilutek, which is already authorized in the European Union. Riluzole is indicated for use in the treatment of amyotrophic lateral sclerosis.

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Basis of recommendations

The CHMP’s recommendations are based on routine inspections carried out by German and Dutch authorities at the Taloja site in India during March 2015. The inspection revealed misrepresented data for different trials performed at the Taloja site.

Based on the inspection, the EMA has doubts as to the reliability of data provided for research between March 2013 and March 2015, and so the EMA has taken actions for few drugs that were under research at the Taloja site in India. The review was started by CHMP on April 1, 2016, based on the request of German authorities.

The drugs and respective actions from the EMA include the following:

  • Riluzole Alkem, a medicine yet to be launched in the EU, has been suspended because the studies conducted at Taloja, India, were found to be doubtful. The EMA requires another data for authorizing the drug Riluzole Alkem in the EU.
  • The drug Ibuprofen Orion, which is under evaluation, cannot be authorized based on the studies from Alkem’s Taloja site. The company will require alternative studies for the approval process of Ibuprofen Orion.
  • Cefuroxime Ingen Pharma will be considered for authorization based on the data from other sources that have already been provided by the company.
  • Cefuroxime Amgen will remain on the market in the EU because data from alternate studies has already been provided, and the data supports the positive impact of the drug.

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