Merck announced on Thursday that 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 purchased the drug, MK-7110, through its $ 425 million acquisition of private biopharmaceutical company OncoImmune late last year.
An interim analysis of clinical trial data suggested that 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 revealed in February that US regulators had requested more data on drugs beyond the third phase, which had already taken place. At the time, the company said it no longer expected the US to supply the drug in the first half of 2021.
Now, because of “regulatory uncertainties” and the time and resources required to provide additional data, Merck said it has decided to discontinue drug development and instead focus its efforts on advancing the other drug Covid-19, as well as on accelerating Johnson & Johnson vaccine production.
“Based on the additional research that would be needed – new clinical trials as well as research on scale production – MK-7110 would not be expected to become available until the first half of 2022,” the company said in a statement. of press.
The announcement marks another disappointment for Merck in its efforts to combat the pandemic.
In January, it announced it would end development of the two Covid-19 vaccines. In early studies, both vaccines generated immune responses that were lower than those seen in people who recovered from Covid-19, as well as those reported for other vaccines, according to the company.
While Merck discontinued MK-7110, the company said it would go ahead with its oral antiviral drug, molnupiravir, in a third-phase clinical trial testing non-hospitalized patients with Covid-19.
“We continue to make progress in the clinical development of our antiviral candidate molnupiravir,” Roy Baynes, Merck’s medical director, said in a statement. The dose-finding data from these studies are consistent with the mechanism of action and provide significant evidence for the antiviral potential of the 800 mg dose.
– Reuters contributed to this report.