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EU regulator approves injectable HIV drug that experts say could help stop transmission
EUROPEAN UNION, JUL 25 – Lenacapavir showed 99.9% to 100% effectiveness in Phase 3 trials and could expand HIV prevention options for those facing adherence challenges with daily pills.
- On Friday the Committee for Medicinal Products for Human Use at the EMA adopted a positive opinion under accelerated review, marking the first twice-yearly HIV PrEP option in the EU.
- With HIV incidence climbing, earlier this month the WHO recommended offering lenacapavir as an additional PrEP option in Europe.
- According to PURPOSE 1 trial data, lenacapavir prevented all HIV infections among 2,134 participants and was generally well-tolerated with no new safety concerns.
- In addition to accelerated review, the CHMP also adopted a positive EU-M4all opinion to facilitate WHO prequalification and national reviews, and Dr Dietmar Berger said it has the potential to become a critical tool for public health.
- Following EC approval, lenacapavir will be marketed as Yeytuo with an extra year of market exclusivity.
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43 Articles
European Medicines Agency recommends authorisation of HIV-preventing medicine, which may help stop the spread of the virus.
·Mexico City, Mexico
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The drug showed high efficacy.
·Bratislava, Slovakia
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Associated Press News+19 Reposted by 19 other sources
EU regulator approves injectable HIV drug that experts say could help stop transmission
The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. Scientists say this could help end the virus' transmission.
·United States
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Total News Sources43
Leaning Left8Leaning Right7Center8Last UpdatedBias Distribution35% Left, 35% Center
Bias Distribution
- 35% of the sources lean Left, 35% of the sources are Center
35% Center
L 35%
C 35%
R 30%
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