Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir.
The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral drugs.
In February, the FDA denied the approval of lenacapavir after concluding that the borosilicate glass vials containing the drug were incompatible with the medication as they could result in contamination with “sub-visible” glass particles.
Late last year, FDA placed a clinical hold on the use of the drug candidate in borosilicate vials for ongoing studies.
Foster City, California-based Gilead has also studied oral formulations of the drug.
Gilead included data on the drug used in vials made from aluminosilicate glass in its most recent new drug applicat…