FDA denies Lenacapavir approval due to issues with glass vials

The Food and Drug Administration (FDA) has refused to approve an antiretroviral HIV treatment from Gilead Sciences due to concerns about the glass vials used to store the treatment, reports Reuters, citing Gilead’s statement.

In a full response, the FDA highlighted issues related to the compatibility of Lenacapavir with the proposed borosilicate vials.

Gilead, in turn, has said that they plan to provide the FDA with an updated plan in which they’ll store the treatment in another kind of vial in order to obtain approval of the drug.

The issue of vial compatibility has been debated since December 2021, when the FDA suspended testing of a number of candidate treatments, including HIV treatment and prevention, due to possible ingress of “invisible glass particles” into the solution of the drug.

Lenacapavir, from Gilead, is designed for subcutaneous injections every six months and was developed to treat patients with multiple drug resistant HIV. Lenakapavir acts by interfering with the activity of the HIV capsid, a protein structure that protects the genetic material of the virus.