Merck says new COVID-19 medication cuts the risk of hospitalization and death

Photo: Jeff Lagasse/Healthcare Finance News

In an effort to push back against the still-ongoing global COVID-19 pandemic, Merck, in partnership with Ridgeback Biotherapeutics, is touting the benefits of an investigational oral antiviral medication known as molnupiravir, saying it reduces the risk of hospitalization and death among people with mild-to-moderate cases of the coronavirus.

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by about 50%, according to Merck; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients.

Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.

At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration, recruitment into the study is being stopped early due to the results, the company said. Merck plans to submit an application for Emergency Use Authorization to the FDA soon based on these findings, and plans to submit marketing applications to other regulatory bodies worldwide.

Countries around the globe have taken notice. Thailand, for instance, is in talks with Merck to purchase 200,000 courses of the experimental pill, joining South Korea, Taiwan and Malaysia, according to Reuters. The Philippines is currently running a trial on the pill, and hopes a domestic study on its efficacy will eventually result in public access to the treatment.

9News, meanwhile, reports that the Australian government has agreed to buy 300,000 courses of molnupiravir, if cleared by regulators. 

Early results in the U.S. have been promising. Merck's testing required patients to have laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within five days of study randomization, and at least one risk factor associated with poor disease outcome.

Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups. Its efficacy was not affected by the timing of symptom onset or the underlying risk factor. And based on the participants with available viral sequencing data – approximately 40% – molnupiravir demonstrated consistent efficacy across the viral variants Gamma, Delta and Mu.

The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).

WHAT'S THE IMPACT?

If the pill is cleared for consumers by U.S. regulators, it would be the first oral medication shown to treat the coronavirus, a contrast to other available treatments that require IV or injection. A pill taken at home could potentially lift some of the burden on hospitals and contain outbreaks in economically disadvantaged areas that lack access to more expensive infusion therapies.

In anticipation of regulatory clearance, Merck has been producing molnupiravir at risk, and expects to produce 10 million courses of treatment by the end of 2021, with more doses expected in 2022.

Earlier this year Merck entered into a procurement agreement with the U.S. under which the company will supply about 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the U.S. FDA.

Merck said it plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries' relative ability to finance their health response to the pandemic.

Previously, Merck announced it had entered into nonexclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate its availability in more than 100 low- and middle-income countries, following approvals or emergency authorization by local regulatory agencies.

THE LARGER TREND

Having a new tool to combat the pandemic could be critical, given that in the U.S. vaccine hesitancy continues to be a major concern. Though the vaccines have shown to be highly effective at preventing severe illness or hospitalization from COVID-19, Sermo's Real Time Barometer showed in May that more than 72% of physicians surveyed said that patients continue to voice concerns over vaccine side effects.

Still others have reported ongoing misinformation discouraging people from getting vaccines. And close to 30% of physicians reported encountering patients who have skipped their second dose due to unpleasant side effects from the first dose, or concerns over side effects.
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com