Merck & Co Inc. has announced a start of last-stage trials for its HIV drug, known as islatravir. The event comes months after the U.S. Food and Drug Administration (FDA) suspended the study, citing safety issues.
As the company states, the Health Department agency reconsidered the plan, agreeing to lower the dose of the once-a-day pills to treat patients with HIV.
Back in December 2021, the FDA completely shelved six studies aimed at developing HIV therapies. Concurrently, the regulator suspended 7 projects, noting some patients were experiencing a lower level of immune system cells that help combat infections.
Merck reported resuming clinical trials of isletravir at lower doses, particularly for adults with HIV-1.
Several higher-dose projects using isletravir are also under clinical hold.