Health

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

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Based on a feed excerpt; full article content has not been acquired. Source evidence retrieved 02/11/2026, 21:06:25 UTC.

Briefings

The FDA granted tentative approval to Dr. Reddy’s Laboratories to produce a generic version of lenacapavir, an injectable HIV prevention drug. This approval, expected to begin shipping next month, aims to expand access for low- and middle-income countries by making the drug available at a cost of $40 per person annually, comparable to daily tablets. The brand-name Yetzugo is marketed by Gilead Sciences and was previously approved by the FDA last year.

Key points

• Dr. Reddy’s Laboratories received tentative FDA approval to manufacture a generic version of lenacapavir, a six-monthly injectable HIV prevention drug.
• The generic drug is projected to cost $40 per person annually, a price point comparable to daily tablets.

Context

This approval represents a significant step for global health, as Dr. Reddy’s is one of the world’s largest generic drugmakers. The initiative is driven by global health organizations to ensure lenacapavir becomes accessible in lower-income countries as quickly as possible.

Limitations

The evidence is limited to the FDA's tentative approval announcement and company plans. Specific launch dates beyond 'next month' are not provided, and the exact number of low- and middle-income countries targeted is not specified.

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