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STAT+: FDA OKs generic HIV prevention shot, widening access for lower-income countries

By · Via STAT Health · Published by Everything Blog

In short

Dr. Reddy’s Laboratories will begin distributing the generic HIV prevention shot next month across dozens of low- and middle-income nations. Marketed in the United States as Yetzugo, the brand-name equivalent gained FDA approval last year. Patients receiving the generic formulation will pay $40 per year, which matches the ongoing cost of daily pills. This biannual dosing schedule offers a transformative, highly protective alternative to traditional oral prevention methods.

Key points

  • The newly approved generic injection requires only one administration every six months in…: The newly approved generic injection requires only one administration every six months instead of daily pill regimens.
  • Pricing the drug at $40 annually puts long-acting HIV protection on equal financial footi…: Pricing the drug at $40 annually puts long-acting HIV protection on equal financial footing with daily tablets.
  • Broad distribution across low- and middle-income countries provides vital access to virtu…: Broad distribution across low- and middle-income countries provides vital access to virtually complete protection against HIV transmission.

Sources checked by our analysis pipeline: 1

After months of anticipation, the Food and Drug Administration gave tentative approval to Dr. Reddy’s Laboratories to make a generic version of a groundbreaking HIV prevention medicine, a key step in widening access for dozens of low- and middle-income countries.

The company, one of the world’s largest generic drugmakers, plans to start shipping the medicine next month as part of an effort propelled, in part, by several global health organizations to ensure the drug becomes available in lower-income countries as quickly as possible. The annual cost per person will be $40, comparable to daily tablets.

Known as lenacapavir, the injectable drug is widely seen as a game-changing tool for eradicating HIV because it offers virtually complete protection against contracting the virus with just one administration every six months. The brand-name version, which is known as Yetzugo in the U.S., is marketed by Gilead Sciences and was approved by the FDA last year.

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