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Unitaid and partners joint press release
- The US Food and Drug Administration (FDA) has approved the first generic long-acting injectable for HIV prevention, just 16 months after the approval of the originator product. A novel regulatory strategy resulted in one of the fastest timelines to approval for a major HIV innovation to date.
- Developed by Dr. Reddy’s Laboratories with financial, technical, and regulatory support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the product’s development and regulatory filing and speed up lenacapavir’s market entry.
- Under the existing partnership agreement, Dr. Reddy’s lenacapavir injection will be available at US$40 per person per year for the 120 low- and middle-income countries included in Gilead’s voluntary license.
- First supplies of the generic are expected to reach countries before the end of the year, with broader availability in 2027.
Read the full press release here.
Source : Unitaid
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