Business EconomyPosted at: Nov 2 2026 8:35PM


Dr Reddy’s gets tentative USFDA nod for twice-yearly HIV prevention injection

Hyderabad, Nov 2 (UNI) Dr. Reddy’s Laboratories Ltd has received tentative approval from the US Food and Drug Administration (USFDA) for its twice-yearly injectable lenacapavir, paving the way for expanded access to HIV prevention in 120 countries outside the United States.
The approval was granted under the US FDA’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme, the Hyderabad based pharma ginat said in a release on Monday.
The development of the injectable formulation and its accelerated regulatory pathway were supported by Unitaid, Wits RHI and the Clinton Health Access Initiative (CHAI).
Under an existing agreement, the drug will be made available at USD 40 per person per year across 120 countries covered by Gilead Sciences’ voluntary licensing arrangement.
The first supplies are expected to reach eligible countries before the end of 2026, with wider availability planned across participating countries in 2027.
Lenacapavir is a long-acting injectable medicine for HIV prevention that is administered twice a year, offering an alternative to daily oral preventive medication.
The tentative USFDA approval is expected to facilitate wider access to long-acting HIV prevention in countries covered by the licensing arrangement.
UNI KNR CDS
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