Sputnik V COVID-19 Vaccine to be Produced in India with Hetero Collaboration
• The Russian Direct Investment Fund (RDIF) and Hetero have agreed to produce over 100 million doses per year of the Sputnik V vaccine in India.
• Production is slated to commence in early 2021, with the aim of providing an efficient solution during the COVID-19 pandemic.
• Clinical trials for Sputnik V are ongoing in multiple countries, including Phase II-III trials in India, to assess its efficacy.
• Interim clinical trial results indicate a 95% efficacy rate 42 days after the first dose, with the vaccine priced at under $10 for international markets.
FDA Accepts Gilead's Lenacapavir for HIV Prevention with Priority Review
• The FDA has accepted Gilead's NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP).
• Lenacapavir demonstrated 100% risk reduction in cisgender women and 96% risk reduction in a diverse population, compared to background HIV incidence.
• The FDA has granted priority review with a target action date of June 19, 2025, potentially making it the first twice-yearly HIV prevention option.
• Gilead is also pursuing global access, including submissions to the EMA and voluntary licensing agreements to facilitate availability in low- and middle-income countries.
Recent Advances in Small Molecule Therapies: FDA Approvals and Clinical Trial Updates
• The FDA approved Bristol Myers Squibb's Cobenfy for schizophrenia, marking the first new mechanism of action in over 50 years by targeting muscarinic acetylcholine receptors.
• Gilead Sciences has entered voluntary licensing agreements to expand access to lenacapavir, an HIV-1 drug with a novel mechanism, in resource-limited countries.
• AstraZeneca's Tagrisso received FDA approval for unresectable non-small cell lung cancer after demonstrating progression-free survival in the LAURA trial.
• Pfizer voluntarily withdrew Oxbryta, a sickle cell disease treatment, from all markets due to post-marketing clinical trials revealing a higher rate of vaso-occlusive crisis.
Dr. Reddy's and Hetero Partner with Gilead to Produce Generic HIV Drug Lenacapavir
• Dr. Reddy's and Hetero have signed non-exclusive licensing agreements with Gilead to manufacture and market generic lenacapavir in 120 countries.
• Lenacapavir, marketed as Sunlenca, is approved for multi-drug resistant HIV-1 and is under investigation for HIV prevention (PrEP).
• The agreement allows Dr. Reddy's to handle technology transfer, clinical studies, and product launches in the specified markets.
• This collaboration aims to provide affordable access to lenacapavir in low- and middle-income countries with high HIV prevalence.
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