Merck (NYSE:MRK) announced Thursday it will end the development of its experimental drug for patients hospitalized with severe COVID-19 after the Food and Drug Administration asked the company to provide additional data to support an emergency use authorization.
New Jersey-based Merck acquired the drug, MK-7110, through its $425 million acquisition of privately held biopharmaceutical company OncoImmune late last year.
An interim analysis of clinical trial data suggested the drug improved the chances of recovery for the sickest patients with Covid-19 and reduced the risk of death or respiratory failure.
However, Merck disclosed in February that U.S. regulators had asked for more data on the drug beyond the phase three trial already conducted. At the time, the company said it no longer expected to supply the U.S. with the drug in the first half of 2021.
Now, due to "regulatory uncertainties" and the time and resources needed to provide the additional data, Merck said it decided to discontinue the development of the drug and instead focus its efforts on advancing its other COVID-19 drug as well as accelerating production of the Johnson & Johnson (NYSE:JNJ) vaccine.
"Based on the additional research that would be required – new clinical trials as well as research related to manufacturing at scale – MK-7110 would not be expected to become available until the first half of 2022," the company said in a press release.
While Merck is discontinuing MK-7110, the company said it will move forward with its oral antiviral drug, molnupiravir, in a phase three clinical trial testing non-hospitalized patients with COVID-19.
MRK shares gained 71 cents to $77.11.
