FDA Approves Gilead Sciences' HIV Drug For Adults With Limited Treatment Options

The U.S. Food and Drug Administration approved Gilead Sciences Inc.'s (GILD) Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with HIV-1, whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. Sunlenca is given in combination with other antiretroviral(s).

After the starting dose is completed, Sunlenca is administered as subcutaneous (under the skin) injections once every six months, allowing convenient dosing for patients.

The FDA approval for Sunlenca is supported by data from the Phase 2/3 CAPELLA trial, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV-1 who are heavily treatment experienced.

The FDA warned that patients should not receive Sunlenca if they also take certain drugs that cause reduced levels of Sunlenca. This may result in losing virologic response and developing viral resistance.

The FDA granted Sunlenca Priority Review, Fast Track and Breakthrough Therapy designations for this indication.

Gilead Sciences noted that lenacapavir, alone or in combination, is not approved by any regulatory authority outside of the United States, United Kingdom, Canada or the European Union for any use. The European Marketing Authorization applies to all 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein.

Additional regulatory filings and decisions by regulatory authorities are anticipated to continue in 2023.

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