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 The Paris prosecutor had already launched a preliminary
investigation into the authorization and marketing of Depakine in
2016, after France's social affairs inspection agency IGAS
criticized 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.
Sodium valproate, the active molecule in Depakine, has been on the
market since 1967 to treat epilepsy and bipolar disorder. It
features on the World Health Organization's (WHO) list of "essential
medicines".
Depakine, which lost its patent in 1998, is prescribed in more than
100 countries. It is also sold under the names Depakote and Epilim.
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IGAS estimated that between 2006 and 2014, 425 to 450 babies
suffered congenital birth defects or were stillborn following
exposure to Depakine.
Marine Martin, president of victims association APESAC, said on
Twitter she was "extremely satisfied to see the criminal proceedings
she launched in 2016 reach an important threshold".
"Sanofi will have to deal with the tens of thousands of poisoned
victims, out of which more than a hundred died".
The French firm become aware of the risk of fetus malformation in
the 1980s and then, around 2003, of the drug's impact on the
neurological development of the fetus, with a risk of autism or
learning difficulties.
The U.S. Food and Drug Administration warned in 2013 that valproate
should not be taken during pregnancy.
(Reporting by Benoit Van Overstraeten, Matthias Blamont; Editing by
Christian Schmollinger and Alexander Smith)
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