FDA Seeks More Data on Merck Covid Drug

FDA has asked Merck for additional data beyond a recently completed Phase 3 study of investigational Covid-19 drug MK-7110, an immune modulator. Previously, the company and the U.S. government penned a $356 million deal to supply the U.S. with 60,000 to 100,000 doses of MK-7110. Based on the data request, Merck no longer expects to supply MK-7110 in the first half of 2021, the company said in its annual report.

Merck acquired the drug when it bought privately held OncoImmune late last year. At that point, MK-7110 was already in a Phase 3 trial. The company said topline results showed a 60% higher probability of improvement in clinical status compared to placebo. The company said that full results from the study, which were consistent with the topline results, were received earlier this month and they will be submitted soon for publication in a medical journal.

Merck said it is actively working with FDA to address the agency's concerns.