European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced that the European Medicines Agency (EMA) has validated the company’s marketing authorisation application (MAA) seeking approval of cabotegravir (CAB) long-acting injectable for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1.

Cabotegravir long-acting for HIV prevention is administered six times per year, after initiation.

If given priority review by the EMA, CAB for PrEP could be approved in Europe as early as July 2023.

Additional information to the following link: https://www.gsk.com/en-gb/media/press-releases/european-medicines-agency-validates-viiv-healthcare-s-marketing-authorisation-application-for-cabotegravir-long-acting-injectable-for-hiv-prevention/