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Gilead: FDA Places Clinical Hold On Studies Of Injectable Lenacapavir For HIV Treatment & Prevention

Gilead Sciences Inc. (GILD) said that the U.S. Food and Drug Administration has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis.

The FDA's clinical hold is due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir.

The company noted that dosing of oral formulations of lenacapavir will continue. The company remains confident about the future potential of lenacapavir and is committed to resolving this vial quality issue.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not known. There is no cure for HIV or AIDS.

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