Merck to seek emergency authorization for oral Covid treatment after ‘compelling results’ in trials

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  • Merck & Ridgeback Biotherapeutics’ phase 3 trial of the oral antiviral treatment molnupiravir showed that it reduced the risk of hospitalization or death in Covid-19 patients by about 50%.
  • Merck plans to obtain emergency use authorization in the US and submit marketing applications to other global drug regulators.
  • If authorized by regulatory bodies, Molnupiravir could be the first oral antiviral drug for Covid-19.

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Merck and Ridgeback Biotherapeutics plan to seek emergency authorization for their oral antiviral treatment for COVID-19, after the drug showed “compelling results” in clinical trials.

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The drug, molnupiravir, reduced the risk of hospitalization or death by nearly 50% for patients with mild or moderate cases of Covid-19, the companies announced on Friday. Molnupiravir is administered orally and works by stopping the replication of COVID-19 inside the body.

An interim analysis of a Phase 3 study found that 7.3% of patients treated with mollupiravir were hospitalized within 29 days. Of the patients who received placebo, 14.1% were hospitalized or died by day 29. There were no deaths in patients who were given molanupiravir within a 29-day period, compared to 8 deaths in placebo-treated patients.

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All 775 trial participants had laboratory-confirmed symptomatic COVID-19 and were randomly allocated to either molanupiravir or a placebo within five days of the onset of their symptoms.

Not every participant was vaccinated and had at least one underlying factor that put them at greater risk of developing a more severe case of the virus. The most common risk factors include obesity, age over 60, diabetes and heart disease.

The Phase 3 part of the trial was conducted at more than 170 sites in countries including the US, Brazil, Italy, Japan, South Africa, Taiwan and Guatemala.

The study showed that the efficacy of molanupiravir was not affected by the time of symptom onset or the patients’ underlying risk factors. It has been shown to be widely effective and consistently effective in the treatment of all forms of COVID-19 including the highly permeable delta strain.

Reports of adverse events were comparable in both the mollupiravir and placebo groups, with approximately 10% of adverse events reported. Only 1.3% of the mollupiravir group discontinued therapy because of an adverse event—less than 3.4% of the placebo group who did.

On the recommendation of an independent data monitoring committee and in consultation with the US Food and Drug Administration, the positive results have led to early termination of recruitment into the study.

Merck is currently testing molnupiravir in a separate global Phase 3 study to evaluate its efficacy in preventing the spread of Covid-19 in homes.

‘deep Impact’

Merck CEO and President Robert M Davis said in a press release Friday that the company will do everything possible to bring mollupiravir to patients as quickly as possible.

“With these compelling results, we are optimistic that molanupiravir could become an important drug as part of global efforts to fight the pandemic,” he said.

Wendy Holman, CEO of Ridgeback Biotherapeutics, said: “With the virus becoming more widely circulated, and because currently available therapeutic options are infected or need access to a healthcare facility, antiviral treatments that can help keep people with COVID-19 out of the reach of the virus are not available. Can be taken at home for .. in dire need of hospital.”

“We are very encouraged by the results of the interim analysis and hope that molnupiravir, if authorized for use, could have a profound impact in controlling the epidemic,” she said.

emergency use authorization

Merck said on Friday it plans to obtain emergency use authorization for the drug in the US as soon as possible. The company also plans to submit marketing applications to other international drug regulators.

If authorized by regulatory bodies, Molnupiravir could be the first oral antiviral drug for Covid-19. Currently in use antiviral treatments, such as remdesivir, are administered intravenously.

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

Earlier this year, Merck agreed to supply approximately 1.7 million courses of mollupiravir to the US. This agreement is dependent on mollupiravir receiving emergency use authorization or approval from the FDA.

Merck has also entered into supply and purchase agreements for the drug with other governments — pending regulatory authorization — and is in discussions with other governments about the supply of mollupiravir.

The firm on Friday said it plans to implement a level-headed pricing approach based on the World Bank’s country income criteria to ensure that Molnupiravir can be accessed globally. Merck previously announced that it had entered into non-exclusive voluntary licensing agreements with generic manufacturers for molanupiravir, aimed at helping low- and middle-income countries gain access to the treatment. Those agreements are also pending approval or emergency authorization by local regulators.

profit share

Ridgeback received an upfront payment from Merck as part of the companies collaborative development of molnupiravir. The company is also eligible to receive contingency payments based on developmental and regulatory approval milestones.

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

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