Merck announced 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.
Merck, based in New Jersey, acquired the drug MK-7110 through the $ 425 million acquisition of private biopharmaceutical company OncoImmune at the end of last year.
An interim analysis of clinical trial data suggested that the drug improves the chance of recovery for the sickest patients with Covid-19 and reduces the risk of death or respiratory failure.
However, Merck announced in February that U.S. regulators had asked for more information about the drug than the phase three trial that has already been conducted. The company said at the time that the U.S. drug would no longer be available in the first half of 2021.
Because of ‘uncertainties about the regulations’ and the time and resources required to provide the additional data, Merck said he had decided to halt the development of the drug and instead focus his efforts on promoting his other Covid -19 means, as well as to accelerate the production of products. the Johnson & Johnson vaccine.
“Based on the additional research that would be required – new clinical trials as well as large-scale manufacturing research – MK-7110 is expected to be available only in the first half of 2022,” the company said in a press release. said.
The announcement is another disappointment for Merck in its efforts to combat the pandemic.
In January, he announced that the development of his two Covid-19 vaccines would be terminated. In the early trials, both vaccines produced immune responses that were inferior to those seen in people who recovered from Covid-19, as well as those reported for other vaccines, according to the company.
While Merck is discontinuing MK-7110, the company said it would continue its oral antiviral drug, molnupiravir, in a phase three clinical trial testing non-hospital patients with Covid-19.
“We continue to make progress in the clinical development of our antiviral candidate molnupiravir,” Merck medical chief Roy Baynes said in a release. “Dosage 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.