Gilead Sciences has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation (MA) for lenacapavir▼ (Yeytuo®) for pre-exposure prophylaxis (PrEP). Lenacapavir for PrEP is the company’s twice-yearly injectable HIV-1 capsid inhibitor, for use in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk, who weigh at least 35kg.
In the UK, this MA was granted via the International Recognition Procedure, with the European Medicines Agency (EMA) serving as the Reference Regulator. In the EU, the marketing authorisation application (MAA) underwent accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which has identified twice-yearly lenacapavir for PrEP as a product of major public health interest.
The MHRA’s MA follows approvals by the EMA, South Africa, Zambia, and the U.S. Food and Drug Administration (FDA), as well as the World Health Organisation (WHO) guidelines issued in July recommending twice-yearly lenacapavir as an additional PrEP option for HIV prevention.
Peter Wickersham, General Manager, UK & Ireland, Gilead Sciences said: “The MHRA’s authorisation of lenacapavir for PrEP highlights the strength of our clinical data and the potential of this medicine to help address the unmet need in HIV prevention across the UK. This important milestone reflects 17 years of Gilead research that delivered this PrEP option and builds on decades of Gilead’s leadership in HIV innovation.”
Dr. Claire Dewsnap, Consultant Genitourinary Medicine Physician, BASHH immediate past president said: “The authorisation of lenacapavir for PrEP adds a powerful new tool to our HIV prevention strategy. Long-acting PrEP has the potential to overcome barriers such as access challenges, adherence issues, and stigma, particularly among underserved communities. Sexual health services are at the heart of meeting the HIV action plan goals and look forward to expanding the range of services offering prevention. Ensuring access to all forms of HIV prevention will be critical to achieving health equity and meeting national goals for eliminating HIV transmission.”
