FDA lifts clinical hold on Lenacapavir
DTMT Network
The United Food and Drug Administration (FDA) has lifted the clinical hold placed on Gilead Sciences’ Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP).
In a statement released on May 16, 2022, Gilead Sciences said that the decision to remove the clinical hold was taken by the FDA after it reviewed Gilead’s comprehensive plan and the related data on the storage and compatibility of the drug with an alternative vial made from aluminosilicate glass.
It may be recalled that the drug regulator had suspended the clinical trials due to vial compatibility issues over using borosilicate glass vials for storage.
The decision will enable Gilead to resume all activities related to the clinical studies for evaluating injectable lenacapavir for treating HIV treatment and HIV PrEP, the statement added.
“We are pleased to have identified an alternative vial for lenacapavir, and to now advance the robust clinical program for this potential first-in-class long-acting option for HIV treatment and prevention,” Chief Medical Officer of Gilead Sciences Dr Merdad Parsey said.
“Today’s news brings us one step closer to our goal of offering therapeutic options for the diverse communities affected by HIV as we work to end the epidemic for everyone, everywhere,” he added.
The drug was granted Breakthrough Therapy Designation in May 2019 in patients with multidrug resistance and Gilead said that it is working with the FDA to discuss the next steps for the potential use of lenacapavir for the treatment of HIV in this population.
However it may be noted that the drug has not received any approval from the drug regulator and its safety and efficacy is yet to be established, Gilead sad.
Lenacapavir, which is a new drug in development, is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes and if approved, would be the only HIV-1 treatment option administered twice yearly, Gilead informed.
