Merck to seek emergency authorization for oral Covid-19 treatment
An Oklahoma City nurse attends to Covid-19 patients at SSM Health St. Anthony Hospital, Oklahoma City on August 24, 2021.
MerckRidgeback Biotherapeutics and Ridgeback Biotherapeutics will seek emergency authorization to administer their oral antiviral therapy for Covid-19 after it has shown “compelling” results in clinical trials.
Companies announced Friday that molnupiravir had reduced death or hospitalization rates by 50% for those suffering from Covid-19. Molnupiravir, which is taken orally, works to inhibit the growth of Covid-19 within the body.
In an interim analysis, 7.3% of patients who were treated with Molnupiravir in a Phase 3 trial found they had to be admitted within 29 days. A placebo was given to 14.1% of patients. They were either hospitalized or they died within 29 days. Patients who received molnupiravir in the last 29 days did not die. However, 8 deaths were recorded in placebo-treated patients.
Each of 775 trial participants was confirmed laboratory positive for Covid-19 symptoms and randomly received either molnupiravir (or a placebo) within five working days.
Each participant had been unvaccinated or suffered from at least one factor which could increase their risk for contracting the virus. Most common risk factors were obesity (over 60), diabetes, heart disease, and hypertension.
Phase 3 of the trial took place at over 170 locations in several countries, including Brazil, Italy Japan South Africa, Taiwan, Guatemala, South Africa and Japan.
Study results showed that Molnupiravir’s effectiveness was unaffected by patients’ risk factors or the moment of their symptom onset. This drug is also effective in all Covid-19 types, not just the dominant. highly transmissible Delta strain
Both the placebo and molnupiravir groups reported similar adverse events, with approximately 10% of those who had experienced them reporting. Just 1.3% of the molnupiravir group discontinued therapy due to an adverse event – less than the 3.4% of the placebo group who did so.
Due to positive results and the recommendations of an independent Data Monitoring Committee, and after consultation with U.S. Food and Drug Administration, recruitment into the study has been stopped.
Merck is also currently testing molnupiravir for prevention of Covid-19 spreading within household households in an additional global phase 3 study.
The ‘profound impact’
Merck’s CEO, Robert M. Davis said Friday in a press release that the company would make every effort to provide molnupiravir as fast as possible to its patients.
He said, “With these convincing results, we believe that molnupiravir could become an important medicine in the global effort to combat the pandemic.”
Wendy Holman from Ridgeback Biotherapeutics stated that “with the virus still circulating widely, and since therapeutic options are either infused or required access to a healthcare facility to be used, antiviral treatment to stop people with Covid-19 being admitted to the hospital is crucially needed.”
She said, “We are encouraged by the interim analysis results and hope that molnupiravir can have a profound effect in controlling the pandemic.”
Authorization to Use in an Emergency
Merck announced Friday that the company plans to apply for an Emergency Use Authorization (U.S.) as quickly as possible. Merck also intends to file marketing applications with other international drug regulators.
If approved by regulatory agencies, Molnupiravir may be the first orally antiviral medicine to treat Covid-19. The only way to get antiviral treatment for Covid-19 is intravenously.
Merck has already begun producing molnupiravir. Merck expects 10 million doses of the drug by 2021. More will be produced in 2022.
Merck reached an agreement with the U.S. to sell approximately 1.7million molnupiravir doses earlier in this year. The FDA must approve molnupiravir and grant an Emergency Use Authorization for the drug.
Merck has also entered supply and purchase agreements for the drug with other governments – pending regulatory authorization – and is in discussions with other governments about the supply of molnupiravir.
According to the firm, it will implement a tiered pricing model based on World Bank income criteria in order to make molnupiravir accessible worldwide. Merck had previously indicated that it entered into non-exclusive voluntary licensing arrangements for Molnupiravir, which were intended to aid low- and medium-income countries to gain access. These agreements still need to be approved or authorized by emergency authorities.
Merck paid Ridgeback an upfront payment as part of their collaborative development of molnupiravir. The development milestones and regulatory approval milestones will determine whether the company can receive contingent payments.
Merck will split the profits resulting from this collaboration equally with Ridgeback.