28th Oct 2022 08:44
(Alliance News) - GSK PLC on Friday said its majority owned ViiV Healthcare venture has received the European Medicines Agency's validation for its marketing authorisation application for HIV prevention, and said its MAA for respiratory syncytial virus adult vaccine has also been accepted.
The Brentford, London-based biopharmaceutical firm said the marketing authorisation application sought approval of cabotegravir, a long-acting injectable for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1.
Kimberly Smith, 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.6 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."
Cabotegravir long-acting for PrEP is currently approved in the US, Australia and Zimbabwe as Apretude.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK and Pfizer Inc.
Separately, GSK said the EMA has validated the marketing authorisation application for its respiratory syncytial virus older adult vaccine candidate.
It said the application was based on positive pivotal phase III data, which showed high overall vaccine efficacy against RSV lower respiratory tract disease in adults aged 60 years and above.
RSV is a common contagious virus affecting the lungs and breathing passages.
Last week, the Japanese Ministry of Health, Labour & Welfare accepted to review the application for GSK's respiratory syncytial virus vaccine candidate.
Shares were up 2.3% at 1,418.20 pence each on Friday morning in London.
By Xindi Wei; [email protected]
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