The U.S. FDA said 'not yet' to Gilead Sciences' new HIV drug with a complete response letter, citing packaging compatibility issues.
In the letter, the FDA said its decision to reject the California-based biopharma’s long-acting HIV-1 candidate, lenacapavir, was due to chemistry manufacturing and controls (CMC) issues with the glass vials the drug was intended to be distributed in. Specifically, the agency raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution.
Gilead submitted a new drug application (NDA) for lenacapavir to the FDA back in June. The drug, which is administered every six months, is meant for heavily treatment-experienced patients whose HIV-1 has stopped responding to other treatments. If approved, it would be the only HIV treatment on the market to be administered twice yearly.
Despite the CRL, Gilead is not giving up. The company said it will come up with a plan for a different vial type to submit to the FDA.
“People living with multidrug-resistant HIV need new treatment options and we will continue to pursue approval of lenacapavir to offer a much-needed new long-acting treatment option for this population,” said Merdad Parsey, chief medical officer at Gilead.
This is also not the first time Gilead has had its plans shattered by glass.
Back in December, Gilead reported it was pulling two lots of its injectable COVID treatment, Veklury (remdesivir), following a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates in drug vials. At the time of the report, the company had received no news of adverse events related to the recall.
