21st Dec 2020 09:18
(Alliance News) - GlaxoSmithKline PLC said it has received marketing authorisation from the European Commission for ViiV Healthcare Ltd's Vocabria to be used with Janssen Pharmaceuticals Inc's Rekambys and Edurant.
ViiV Healthcare is a US specialist HIV joint venture majority owned by Glaxo, with pharmaceutical companies New York-based Pfizer Inc and Osaka, Japan-based Shionogi Inc as shareholders. Belgium-based pharmaceutical development company Janssen is part of Johnson & Johnson, headquartered in New Brunswick, New Jersey.
Glaxo said the new treatment can enable HIV patients to reduce the days they receive treatment, from 365 days to 12 or six per year.
Marketing authorisation was based on the phase III Atlas, Flair and Atlas-2M studies, which included more than 1,200 participants from 16 countries.
"This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase," said Glaxo.
ViiV Healthcare Chief Executive Deborah Waterhouse said: "We saw from the patient reported outcomes in our pivotal clinical trials that approximately nine out of 10 people who switched to the long-acting regimen preferred this over their previous daily oral tablets. It will potentially change the treatment experience for some people living with HIV by removing the need for daily HIV tablets."
Shares in Glaxo were up 0.8% at 1,367.80 pence in London on Monday.
By Zoe Wickens; [email protected]
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