Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug can­di­date lenaca­pavir got hit with a CRL over CMC is­sues in­volv­ing the type of vials planned for use. Now, the phar­ma is head­ed back to the FDA for round two.

Gilead an­nounced Mon­day af­ter­noon that it had re­filed its NDA sub­mis­sion filled with new CMC da­ta af­ter the FDA es­sen­tial­ly balked at borosil­i­cate glass vials, orig­i­nal­ly used for the non-oral form of lenaca­pavir. The drug can­di­date, which re­cent­ly won a pos­i­tive opin­ion from Eu­rope’s CHMP, is be­ing de­vel­oped for HIV-1 in­fec­tion “in heav­i­ly treat­ment-ex­pe­ri­enced (HTE) peo­ple with mul­ti-drug re­sis­tant (MDR) HIV-1 in­fec­tion.”

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