FDA rejects Gilead’s next big HIV drug over glass vial issues
Gilead on Tuesday received a rejection letter for its latest potential first-in-class HIV drug, as the company said the FDA cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with its proposed container vial.
Regulators previously slapped a clinical hold on 10 trials studying injectable versions of the experimental HIV treatment, known as lenacapavir, due to concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution.
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