Gilead Sciences received the all-clear to pick up studies of its investigational HIV med lenacapavir. Still, the long-acting injectable has yet to fully recover from the sting of its recent glass compatibility snafu.
The FDA has released its clinical hold on injectable lenacapavir for HIV treatment and preexposure prophylaxis, with all trials of the subcutaneous formulation now set to resume, Gilead said Monday. Nevertheless, the drug’s near-term approval prospects remain dimmed after the manufacturing hiccup behind the hold yielded an FDA complete response letter (CRL) in March.
The FDA first clamped down on 10 lenacapavir studies in December, citing concerns about the compatibility of the drug with the borosilicate vials it was being stored in. The combination had the potential to create “sub-visible” glass particles in the lenacapavir solution, Gilead said at the time.
Three months later, the regulator rebuffed injectable lenacapavir’s application in heavily treatment-experienced patients with multidrug-resistant HIV-1 infection. Gilead is also testing an oral version of the drug.
Following receipt of the CRL, Gilead said it would furnish the FDA with a plan and data to use a different type of vial.
Now, the FDA has lifted its clinical hold after reviewing Gilead’s bid to store the drug in an alternative vial made of aluminosilicate glass, the company explained.
Gilead says it will work with study site investigators to “fully resume” lenacapavir development programs “as quickly as possible.”
While the hold was in place, screening and enrollment of participants and dosing of injectable lenacapavir were halted across all trials. Other activities, like patient monitoring, dosing of patients in the trials’ control arms and dosing of oral lenacapavir, continued normally, the company added.
As for the FDA's March rejection in heavily treatment-experienced patients, Gilead said it’s working with the agency to discuss “next steps for the potential use of lenacapavir for the treatment of HIV in this population.”
Gilead sent its lenacapavir application to the FDA in June 2021 and snagged a priority-review tag. Lenacapavir also scored a breakthrough-therapy designation back in May 2019.
The lenacapavir studies affected by the clinical hold ranged from early- to late-stage development, including two phase 3 trials.
Gilead’s trial pause last winter coincided with another clinical hold on Merck’s HIV candidate islatravir. The company received 13 clinical holds on the med, seven of which were late-stage trials.
Merck said the FDA’s decision stemmed from concerns with white blood cell counts in patients who took the drug rather than a quality issue like Gilead’s.
Separately, Gilead in December had to recall two lots of its COVID-19 antiviral Veklury, also known as remdesivir, after a customer complaint flagged the presence of glass particulates in the injectable med. Following its own investigation, Gilead said at the time it was unsure how the particulates cropped up in the Veklury vials.