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Merck applies for emergency approval for oral Covid-19 remedy

merck-applies-for-emergency-approval-for-oral-covid-19-remedy

A nurse tends to a Covid-19 patient at SSM Health St. Anthony Hospital in Oklahoma City on August 24, 2021.

Nick Oxford | Reuters

Merck and Ridgeback Biotherapeutics are planning emergency approval for their oral antiviral treatment for Covid-19 after the drug has shown “convincing results” in clinical trials.

The drug molnupiravir reduced the risk of hospitalization or death in patients with mild or moderate cases of Covid-19 by around 50%, the companies said on Friday. Molnupiravir is given orally and works by blocking the replication of Covid-19 in the body.

An interim analysis of a Phase 3 study found that 7.3% of molnupiravir-treated patients were hospitalized within 29 days. Of the patients who received a placebo, 14.1% were hospitalized or died on day 29. No deaths were reported in patients receiving molnupiravir within the 29-day period, while 8 deaths were reported in placebo-treated patients.

All 775 study participants had laboratory-confirmed symptomatic Covid-19 and were randomly given either molnupiravir or a placebo within five days of their symptoms onset.

Each participant was unvaccinated and had at least one underlying factor that placed them at a higher risk of developing a more severe case of the virus. The most common risk factors included obesity, over 60 years of age, diabetes, and heart disease.

The phase 3 part of the study was conducted in more than 170 locations in countries such as the United States, Brazil, Italy, Japan, South Africa, Taiwan, and Guatemala.

The study showed that molnupiravir’s effectiveness was not influenced by the time when symptoms appeared or the patients’ underlying risk factors. It was also shown to be consistently effective at treating all variants of Covid-19, including the widespread and highly transmissible Delta strain.

Side effects were similar in both the molnupiravir and placebo groups, with approximately 10% reporting adverse events. Only 1.3% of the molnupiravir group discontinued therapy because of an adverse event – less than the 3.4% of the placebo group who did.

Recruitment for the study will be terminated prematurely based on the positive results on the recommendation of an independent data monitoring committee and in consultation with the US Food and Drug Administration.

Merck is also currently testing molnupiravir in a separate global phase 3 study to evaluate its effectiveness in preventing the spread of Covid-19 in households.

“Profound Effect”

Robert M. Davis, CEO and President of Merck, said in a press release on Friday that the company would do everything possible to get molnupiravir to patients as soon as possible.

“With these compelling results, we are optimistic that molnupiravir can become a key drug in the global effort to fight the pandemic,” he said.

Wendy Holman, CEO of Ridgeback Biotherapeutics, added, “As the virus continues to be widespread and the therapeutic options currently available are infused or require access to a health facility, antiviral treatments can be taken at home to help people with Covid-19 from the To keep disease away hospital urgently needed. “

“We are very encouraged by the results of the interim analysis and hope that molnupiravir, if approved for use, can have a profound impact on the control of the pandemic,” she said.

Authorization to use in an emergency

Merck said Friday it plans to apply for emergency approval for the drug in the US as soon as possible. The company also plans to file regulatory filings with other international drug regulatory agencies.

If approved by regulators, molnupiravir could be the first oral antiviral drug for Covid-19. Current antiviral treatments, such as remdesivir, are administered intravenously.

Merck has already started production of molnupiravir. The pharmaceutical giant expects to produce 10 million treatment cycles by the end of 2021 and more doses in 2022.

At the beginning of the year, Merck agreed to supply the United States with approximately 1.7 million molnupiravir courses. This agreement depends on whether molnupiravir receives emergency clearance or approval from the FDA.

Merck has also entered into supply and purchase agreements with other governments for the drug – pending regulatory approval – and is in talks with other governments regarding the supply of molnupiravir.

The company said Friday that it plans to implement a tiered pricing approach based on the World Bank’s income criteria to ensure molnupiravir is available worldwide. Merck has already announced that it has entered into non-exclusive, voluntary licensing agreements for molnupiravir with generic drug companies to facilitate access to treatment for countries with low and middle income. Approvals or emergency approvals from the local supervisory authorities are also pending for these agreements.

Profit sharing

Ridgeback received an upfront payment from Merck as part of the companies’ joint development of molnupiravir. The company is also eligible for contingent payments based on development and regulatory approval milestones.

Profits from the collaboration will be shared equally between Merck and Ridgeback.

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