FDA Requires More Data on Merck's COVID-19 Drug

Merck & Co said Thursday that U.S. regulators have asked for additional data beyond the Phase III study already conducted in order to support potential emergency use authorization of its experimental COVID-19 drug MK-7110.

Based on the feedback from the U.S. Food and Drug Administration (FDA), Merck no longer expects to supply the U.S. government with MK-7110 in the first half of 2021, the company said in its annual report.

The drugmaker – which stopped development of two COVID-19 vaccines last month because they generated immune responses that were inferior to other vaccines – signed an up to $356 million deal in December to supply the U.S. government with 60,000 to 100,000 doses of MK-7110.

Merck picked up the drug when it acquired privately held OncoImmune late last year. At that point, MK-7110, an immune modulator being studied as a treatment for patients hospitalized with severe COVID-19, was already in a Phase III trial.

Topline results showed a 60% higher probability of improvement in clinical status compared to placebo, as well as a more than 50% reduction in the risk of death or respiratory failure were reported by OncoImmune in September.

Merck said in its annual report, full results from the study, which were consistent with the topline results, were received this month and will be submitted soon.

But the FDA has asked for more data beyond the study. Merck said it is actively working with regulators to address their comments.