A new drug for the prevention of HIV/AIDS is one step closer to final approval in Europe, after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The Commission yesterday gave the “green light” to the new injectable treatment that prevents sexual transmission of HIV-1, by administering it twice a year.
The drug lenacapavir, according to studies, was 100% effective when administered to women in sub-Saharan Africa and 99.9% in men and people with a different gender identity, compared to daily preventive treatment.
After being named “breakthrough of the year” for 2024 by the scientific journal Science, now the CHMP has given its positive opinion, with an accelerated evaluation process.
This is the first and only prevention option (PrEP) to be administered every six months, when existing preventive treatments are administered daily.
The final approval decision by the Commission is expected within the year for EU countries, Norway, Iceland and Liechtenstein.
In third countries
The positive opinion also concerned the EU-Medicines for all (EU-M4all) procedure, which allows for simplified assessment for pre-approval by the World Health Organization (WHO) and facilitates national regulatory assessments in low- and middle-income countries.
Ending Infections by 2030
“The positive CHMP opinions are an important step towards a new HIV prevention option that can meet the diverse needs of people in Europe and contribute to ending new HIV infections by 2030,” said Jean-Michel Molina, professor of infectious diseases at Université Paris Cité. “They reflect the strength of clinical data and the potential of long-acting innovations like lenacapavir to address barriers to effective PrEP use.”
Despite ongoing advances in HIV prevention, socio-economic factors such as stigma and discrimination continue to drive disparities in PrEP use, pharmaceutical manufacturer Gilead Sciences said.
In 2023, 24,731 new HIV diagnoses were reported in 30 EU/EEA countries, an 11.8% increase compared to 2022.
The positive CHMP opinion “reflects our commitment to redefining HIV prevention in Europe and globally. Lenacapavir for PrEP can be a critical public health tool, expanding prevention options for people who face the greatest barriers to accessing care,” said Gilead Sciences Chief Medical Officer Dietmar Berger.
Accessible treatment
Gilead also highlighted its pursuit of global access through strategic partnerships and accelerated approval processes.
We note that a recent Gilead scientific forum in Greece, entitled “Ending the HIV Epidemic: From Vision to Action”, was attended by the Minister of Health, representatives from EACS and ECDC, the Hellenic Society for the Study and Treatment of AIDS (EEMAA) and public health agencies, health professionals and patient representatives.
The purpose of the forum was to bridge theory with practice in the national HIV prevention and treatment strategy, constituting a key reference point for the development of health policies, in alignment with the European goal of zero new infections by 2030.
The discussions focused on critical issues, such as:
- The need for early diagnosis and better linkage to care,
- Ensuring long-term adherence to treatments,
- Maintaining the sustainability of health systems and
- Addressing social barriers such as stigma and discrimination.
The participants emphasized that only through coordinated actions can substantial and lasting results be achieved, which is why they characterized the cooperation between the state, science and community as the only way forward, sending the message “Together we can make a difference”.
