EMA No Longer Accepts Alkem Laboratories’ Studies for EU Drug Approvals

The EMA is no longer accepting clinical trial data from Indian drugmaker Alkem Laboratories to support drug approvals in the EU after an inspection revealed data misrepresentations.

German and Dutch authorities discovered that Alkem misrepresented data from two trials conducted in 2013 and 2014 at its Taloja site, casting doubts on the reliability of its work.

As a result, the EMA’s Committee for Medicinal Products for Human also recommended specific actions for drugs with trials supported by Alkem, including the suspension of Riluzole Alkem’s marketing authorization and a hold on Ibuprofen Orion’s marketing approval.