The European Medicines Agency (EMA) has issued a positive opinion, on a accelerated regime, for the authorization of a new preexposition prophylaxis (prep) against HIV-1 infection. The treatment blocks the virus replication with only two injections a year.
Is the first injectable drug with semester administration for prevention. Foto: Shutterstock
The treatment is based on Lenacapavir, an innovative capsid inhibitor, which, administered subcutaneously, acts from the first phases of the HIV viral cycle, blocking the virus replication.
It is the first injectable drug with semester administration intended exclusively for the prevention of HIV infection – a potential discovery to revolutionize access and adhesion to prophylaxis, especially among people with an increased risk of exposure.
According to the Committee for Medicinal products for human use (CHMP), the drug is recommended for use in combination with safe sexual practices, both in adults and adolescents, in order to reduce the risk of HIV-1 infection.
An overall synchronized assessment
The evaluation of Lenacapavir has been parallel to the European Union Square and for countries outside the EU, through the EU-M4all program. It has the role of supporting the global regulation and strengthening the protection of international public health.
The most important scientific discovery of 2024
The importance of discovery was also underlined by Science magazine, which designated Lenacapavir as the most important scientific achievement of 2024, in its annual Breakthrough of the Year.
It is for the first time that HIV preventive treatment gets such an international recognition. The decision, adopted by the Committee for Medicinal products for human use (CHMP), marks a historical moment in the fight against the HIV virus.
