News | Infectious Diseases, Vaccines & Antimicrobials | HIV
Gilead launches groundbreaking programme as talks begin for twice-yearly anti-HIV jab registration in South Africa
Time to read: 01:59
Time to listen: 02:06
Published on MedED: 28 October 2024
Type of article: News
MedED Catalogue Reference: MNG0054
Category: News
Category Cross-reference: Infectious Diseases, Vaccines
Keywords: HIV, Gilead, Lenacapavir, SAHPRA
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28 October 13:45
Gilead Sciences, the maker of a twice-yearly anti-HIV injection containing lenacapavir, is working with South Africa's Health Products Regulatory Authority (Sahpra) to expedite local registration of the shot, which is targeted at preventing HIV.
Generic versions are expected to be available in 2027 for 120 high-HIV-rate countries, including South Africa. While lenacapavir is already approved in some countries for treating HIV-infected individuals resistant to other therapies, it has yet to be authorised for use as pre-exposure prophylaxis.
Sahpra, despite its expertise, faces staffing challenges that delay medicine reviews. The agency aims to leverage the EU Medicines for All (EU-M4all) initiative to expedite the evaluation process through a joint review with the European Medicines Agency.
Gilead plans to file for registration with Sahpra once the EU-M4all review is complete.
Meanwhile, the National Health Department is considering a request for information (RFI) to gauge pricing and availability from manufacturers ahead of approval, an unprecedented move to save time and prevent HIV infections during the registration process.
This story was compiled from various resources including:
21 October 2024 | Bhekisisa | Talks have started to get the twice-yearly anti-HIV jab registered in SA
2 Octover 2024 | MedicalXpress | Gilead licenses HIV-prevention drug to generic drugmakers
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7 October 2024 | Gilead to provide HIV prevention drug more cheaply to 120 countries, but concerns raised regarding excluded countries
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