FOSTER CITY (dpa-AFX) - The U.S. Food and Drug Administration has lifted the clinical hold placed on Gilead Sciences Inc.'s (GILD) Investigational New Drug Application or IND to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis or PrEP.
The move comes following the agency's review of Gilead's comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.
The FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue.
Following Monday's decision from the FDA, Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible.
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