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U.S. FDA puts Merck’s HIV drug trials on hold -Breaking


© Reuters. FILE PHOTO: The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid

(Reuters) – Merck & Co said on Monday the U.S. Food and Drug Administration has placed clinical holds on trials testing the company’s HIV drug islatravir.

According to the company, this is due to the observation of T-cell count drops in certain participants who received the drug during clinical trials. T-cells, which are an important component of our immune system and help us fight infection, play a vital role.

Six studies about islatravir have been placed on clinical hold by the FDA, and seven others on clinical hold.

Merck announced that it would stop giving the drug to participants in the HIV prevention studies, which include oral, implant, and injectable forms of Islatravir.

Gilead Sciences Inc Merck (NASDAQ) announced on Monday that Merck had stopped a midstage study evaluating Gilead’s HIV treatment lenacapavir and islatravir. The decision came after the dosing was stopped earlier in November.

Merck also suspended enrollments in the late-stage trial for islatravir.

Merck explained that new research on the drug cannot be started while FDA clinical holds remain in place.

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