The European Medicines Agency (EMA) has recommended the approval of Gilead Science’s Lenacapavir, an injection administered twice a year, for the prevention of HIV infection in adults and adolescents, the laboratory announced on Friday.
This support could make Lenacapavir the first option to prevent semi-annual HIV in the European Union, making it possible to reduce the risk of infection by HIV-1 of sexual origin in adults and adolescents at risk.
Lenacapavir constitutes a long -lasting alternative to daily oral tablets and other shorter effect solutions, facilitating the fight against disease, especially for people encountering daily observance difficulties, faced with stigma or limited access to health care.
This decision comes a little more than a month after the treatment received the green light from the American regulatory authorities, where it is marketed under the name of Yeztugo.
The World Health Organization has also recommended this month the use of this treatment as a tool for prevention of HIV infection.
Any recommendation from the EMA human medication committee must be formally approved by the European Commission, which generally follows the opinion of the regulator.
The European Commission’s decision concerning this drug is expected later in the year, according to Gilead.
In the event of approval, the Lenacapavir would benefit from an additional year of commercial exclusivity on the European market and would be marketed under the name of Yeytuo, said the laboratory.
The Lenacapavir, which belongs to the class of capsid inhibitors, has proven to be effective at almost 100 % to prevent HIV infection during large clinical trials conducted last year.
(Report by Mariam Sunny in Bengaluru; edited by Alan Barona)