Therefore,
Does new promising treatment against:
A new preventive treatment for HIV. For example, Yeztugo, was approved in June 2025 in the United States, and at the end of July Europe. However, Announced as being revolutionary, he must now go through the final validation stages in Europe and France. Therefore, How long does such a procedure take? Furthermore,
Approved in the United States in June 2025, a new medication is preparing to revolutionize the preventive management of HIV. Therefore, The Lénacapavir. Therefore, marketed by the American pharmaceutical company Gilead under the name of Yeztugo, will be injectable only twice a year as pre-exhibition prophylaxis (PREP).
The prepl is prescribed for people who have not been infected with HIV. Similarly, but being exposed to great risks of being, such as drug users or sex workers, for example. Similarly, does new promising treatment against So far, it was mainly prescribed in the form of oral tablets to be taken daily.
An efficiency of almost 100 %, few side effects, a very low injection frequency … However, Its only defect decree for the moment would be its annual cost, almost 30,000 dollars in our American neighbors.
How long could this treatment so coveted to arrive in France? In addition, And what is the procedure to follow for a drug. However, already having market authorization in the United States, is approved in our country?
A drug approved in the United States is not automatically in France – Does new promising treatment against
It is not because a drug is put on the market in the United States. and that it was therefore approved by the Food and Drug Administration (FDA), that it will be automatically in France. He must necessarily be validated, again, by the French authorities.
There are does new promising treatment against different possible ways for a drug to obtain this authorization in France and, more broadly, in Europe.
- The drug can be approved in France by The National Medicines Safety Agency (ANSM) At the national level, only.
- The drug may be subject to a centralized procedure at European level. It is therefore approved by the European Commission With an authorization valid in all the member states of the. European Union. This procedure is compulsory for all drugs considered to be innovative, of which Yeztugo is a part.
- If the drug has already been authorized in EU member states. it may be subject to a procedure called decentralized or mutual recognition.
In some cases. when there is an urgent medical need and it is a serious pathology, the drug can receive a early access. This means that by awaiting permission for permanent marketing, it is approved more quickly.
Accelerated European approval for Yeztugo
The Yeztugo is one of those drugs that have received an accelerated assessment. It has just been approved by the European Medicines Agency (EMA) on July 25, 2025. It is therefore authorized does new promising treatment against in the European Union. The EMA website explains that the drug “Yeztugo was evaluated by the CHMP. the EMA human medicine committee, according to an accelerated calendar because it is considered to have a major public health interest in the EU and in the rest of the world ».
He now still has to be officially approved by the European Commission. a phase which takes a little less than two months generally.
Finally. the High Authority for Health (HAS) will make an assessment on the drug to determine how reimbursed it will be. This final step can take between a few months and up to 1 year.
Thus. taking into account all these procedures, we can anticipate a marketing in France of this medication from the first half of 2026.
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