FDA OKs generic HIV prevention shot, widening access for lower-income countries
The US Food and Drug Administration has granted tentative approval to Dr. Reddy’s Laboratories to produce a generic version of lenacapavir, a groundbreaking injectable medication for HIV prevention. Marketed in the United States by Gilead Sciences under the brand name Yetzugo following its regulatory clearance last year, the drug is widely regarded as a critical breakthrough for combating the virus, offering virtually complete protection against infection with just one shot administered every six months.
Dr. Reddy’s, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month to widen availability across dozens of low- and middle-income countries. Propelled in part by global health organizations seeking rapid deployment in lower-income regions, the rollout establishes an annual treatment cost of $40 per patient. That makes the twice-yearly preventive regimen financially comparable to conventional daily tablets, substantially easing both cost and adherence barriers in resource-limited settings.
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