PARIS: French drugmaker Sanofi said on Tuesday it was being investigated over Depakine, an epilepsy drug which caused birth malfunctions and slow neurological development when taken during pregnancy.

The Paris prosecutor had already launched a preliminary investigation into the authorisation and marketing of Depakine in 2016, after France’s social affairs inspection agency IGAS criticised the slow response of health authorities and Sanofi to the risks related to the drug and its derivatives.

Sanofi said in a statement that the indictment, which may or may not lead to a trial, will allow it to defend itself and to “prove it has always complied with its to duty to inform and been transparent”.

Sanofi, which has repeatedly said it had no intention to compensate or take part in a state-backed compensation mechanism for Depakine, added it would continue to “fully cooperate with judicial authorities”, and was “confident” over the outcome.

Such legal cases can take years and do not necessarily result in significant amounts of compensation in France compared to other jurisdictions such as the United States.

In one of France’s biggest pharmaceutical scandals, privately-owned Servier has so far paid out 152.5 million euros ($169 million) to patients.

Published in Dawn, February 5th, 2020