The U.S. Food and Drug Administration had put the late-stage studies of Merck & Co Inc’s HIV treatment, islatravir, on hold for several months due to safety concerns. On Tuesday, the FDA announced that the trials would resume.
The FDA put six trials using the medication on complete clinical hold and seven others on partial clinical hold in December of last year after finding that certain patients’ immune systems were not functioning as well as others in terms of a component that aids in fighting infections.
Merck announced that it would also resume a mid-stage trial evaluating a low dose of islatravir and Gilead Sciences’ lenacapavir in adults with HIV-1 infections.
Some islatravir studies employing a higher dose are still on clinical hold.
According to the firm, the FDA examined and approved the idea to research lower-dose variations of the once-daily medication for treating HIV patients.
The manufacturer announced, however, that it was giving up on the once-monthly islatravir dose for HIV prevention.
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