The Sanofi group, already under investigation for "aggravated fraud" and "involuntary injury" in the investigation into the marketing of the antiepileptic drug Dépakine, was also entered in the register of suspects for "involuntary murder"
New accusation for Sanofi in the Dépakine investigation. The pharmaceutical group Sanofi Aventis France was indicted for "manslaughter" on Monday 20 July in the investigation into the marketing of the drug Dépakine used for the treatment of epilepsy.
The pharmaceutical group confirmed this after the revelations of Le Monde .
Sanofi was already registered in the register of suspects in February for "aggravated fraud" and "involuntary injury" in the Dépakine investigation.
THE "DÉPAKINE" INQUIRY
In France the investigation against the pharmaceutical giant had been opened in 2016 regarding the Dépakine. According to investigators, the anti-epileptic drug of the Sanofi group would have seriously disabled children exposed in utero to the sodium valproate-based medicine also prescribed for bipolar disorders.
The new charge
The investigation now aims to determine whether the French giant can be held responsible for the death, in 1990, 1996, 2011 and 2014, of four infants aged between a few weeks and a few months whose mothers had taken Depakine during pregnancy, which on the fetus causes malformations and neurological development disorders.
Prosecutors accuse Sanofi of having "continued marketing" the drug despite known risks to patients. In addition, the pharmaceutical group allegedly "informed the competent authorities late and incompletely" about these risks. In addition to having "incompletely provided late, useful information that allows consumers to assess risks".
THE COMMENT OF SANOFI
Sanofi Aventis France added that it had fulfilled all obligations relating to the information provided on Depakine and had denied the allegations.
WHAT THE AMERICAN FDA HAD ESTABLISHED IN 2013
Sodium valproate, Depakine's active molecule, has been on the market since 1967 for the treatment of epilepsy and bipolar disorder. It is included in the World Health Organization (WHO) list of "essential medicines".
However, the intake of this molecule by pregnant women increases the risk of congenital malformations of the fetus or subsequent developmental disorders.
In 2013, the U.S. Food and Drug Administration warned that valproate should not be taken during pregnancy.
DÉPAKINE BANNED FROM 2018 IN FRANCE
The French Inspectorate for Social Affairs (Igas) estimated that between 2006 and 2014, 425-450 babies had congenital birth defects or were born dead following exposure to Depakine.
Since June 2018, France has banned the use of Depakine during pregnancy and for women of childbearing age, except in exceptional circumstances.
THE SANOFI-GSK ANTI-COVID VACCINE BOOKED BY THE EU
Meanwhile, the French laboratory has concluded an agreement with the European Commission for the supply of 300 million doses of the Covid-19 vaccine in preparation with GSK.
"The contract with Sanofi would provide an option for all Member States to purchase the vaccine," said Brussels.
The negotiations between the Commission and the French laboratory have made it possible to create a framework for the purchase of 300 million doses, if a "safe and effective" vaccine is developed.
However, the European executive added to continue "intense discussions" with other vaccine manufacturers.
The doses of the Covid-19 vaccine candidate developed by Sanofi in collaboration with Gsk will also be produced in Italy, France, Belgium and Germany. The product is based on the recombinant technology used by Sanofi to produce a flu vaccine, and on the adjuvant technology of Gsk.
"According to the plans, a Phase 1/2 study will begin in September, followed by a Phase 3 trial by the end of 2020." The Adnkronos reports it. "If the data is positive, regulatory approval could arrive in the first half of 2021. In parallel, Sanofi and Gsk are increasing the production of antigen and adjuvant to produce up to a billion doses per year overall."
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/economia/tutte-le-cure-giudiziarie-in-francia-per-sanofi/ on Mon, 03 Aug 2020 06:19:07 +0000.