ViiV Healthcare Cabotegravir long-acting injectable for HIV prevention gets EMA validation
Cabotegravir long-acting for PrEP is an integrase strand transfer inhibitor (INSTI).;
London: ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has announced that the European Medicines Agency (EMA) has validated the company's marketing authorisation application (MAA) seeking approval of cabotegravir long-acting injectable for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Cabotegravir long-acting for HIV prevention is administered six times per year, after initiation.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: "With approximately 100,000 people in Europe newly diagnosed with HIV each year, this submission is an important step forward in offering expanded options for HIV prevention. Long-acting prevention options, if used appropriately and at scale, could have the potential to transform the shape of the HIV epidemic, and we look forward to continuing to work with community groups, governments, and regulatory authorities to make this option available for those who need it."
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