Covid-19: ANSM rejects the use of fluvoxamine as a curative treatment

The initiative came from two health professionals specialized in psychiatry. In the context of compassionate prescription (CPC), they submitted a file to the National Agency for the Safety of Medicines and Health Products (ANSM) in order to investigate a request for the availability of fluvoxamine in the curative treatment of Covid-19.

What is a Compassionate Prescribing Framework?

The compassionate prescribing framework is the new name, since July 1, 2021, of the temporary recommendations for use or RTU. The ANSM may regulate prescriptions that do not comply with the marketing authorization (AMM), subject to:

• A therapeutic need;
• A presumption of a favorable benefit/risk ratio, in particular based on published scientific data on efficacy and tolerance.

They are established for three years renewable.

Two clinical studies conducted

In the context of fluvoxamine, the two health professionals in psychiatry requested this authorization based on “two randomized controlled clinical trials“ indicates the ANSM, “which justify this request for adults over the age of 24, suffering for less than 7 days from a mild to moderate symptomatic form of COVID-19 certified by a screening test for SARS-CoV-2″.

For the two health professionals, the request was specifically about people “having at least one risk factor for severe form (among those listed by the High Council for Public Health) and for which an alternative treatment with monoclonal antibodies or a direct antiviral anti-SARS-CoV-2 is either contraindicated or not realizable in time”.

No clinical benefit

Fluvoxamine is available and already has a marketing authorization in France and abroad, recalls the ANSM. This molecule is prescribed as part of a treatment for major depressive episodes and obsessive-compulsive disorders. But for the ANSM, “the data available to date, due to their methodological limitations, do not support a clinical benefit of fluvoxamine as a curative treatment for Covid-19 disease”. It therefore refuses to set up a compassionate prescription framework for fluvoxamine in this indication.

A revisable and temporary refusal, subject to additional studies

However, ANSM’s position is not firm and definitive. On the contrary, its press release specifies that its position could be revised at any time “as soon as the results of clinical studies would be likely, taking into account an evolution of the standard care according to the target population, to modify the observation established to date”. It also stresses the need to implement this work.

Finally, she recalls that her refusal does not go against the advice of foreign health authorities, and quotes the National Institutes of Health (NIH) in the United States, for which “the data are currently insufficient to recommend or not this molecule in this context“.