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FDA Authorizes Merck and Ridgeback Biotherapeutics COVID-19 Oral Pill

In the space of 2 days, the FDA approved at-home oral treatments for patients with mild-to-moderate COVID-19, drug that were months in development. Today, it was Merck and Ridgeback Biotherapeutics’ turn.

The at-home oral treatments for COVID-19 patients keep coming. Just 1 day after the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Pfizer’s nirmatrelvir and ritonavir tablet therapy (Paxlovir), the agency gave the EUA green light to Merck and Ridgeback Biotherapeutics’ molnupiravir.

The investigative oral ribonucleoside analog that functions by inhibiting SARS-CoV-2 inhibition was authorized for adults with mild-to-moderate COVID-19 who are at risk of progressing to severe disease. The regimen is not intended for pediatric patients, those already hospitalized with COVID-19, for use over >5 consecutive days, or as a prophylaxis against the pandemic virus.

Though Paxlovir reached an EUA a day prior, the months-long promise of a regulated pill for the treatment of COVID-19 has been associated with molnupiravir for some time. Interim trial data published in early October of this year from the pivotal, global phase 3 MOVe-OUT trial showed molnupiravir reduced patient risk of COVID-19 hospitalization or death by approximately 50%.

Just 28 (7.3%) of patients to receive molnupiravir experienced either outcome, versus 53 (14.1%) patients administered placebo (P = .0012). No patients to receive molnupiravir had died through 29 days post-randomization, versus 8 patients to receive placebo.

Final data from MOVe-OUT showed reduced relative risk of COVID-19-related hospitalization and death was actually only reduced by 30% with molnupiravir versus placebo, however. Approximately 6.8% of the participants treated with molnupiravir were hospitalized or died, as compared to 9.7% of the placebo recipients.

A month later, it received authorization from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), making it the first COVID-19 pill to be regulated by a global health authority.

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Weeks later, the FDA Antimicrobial Drugs Advisory Committee voted to support Merck and Ridgeback’s application on the basis of the supporting phase 3 trial findings.

Now, with the EUA, molnupiravir will be available at a recommended dose of 4 capsules, 200 mg each, taken orally every 12 hours over 5 days, to reduce the risk of severe COVID-19 progression in high-risk, infected adults.

“Based on the strong science behind molnupiravir—a single oral medicine that interrupts replication of the SARS-CoV-2 virus, with data demonstrating a significant reduction in the risk of hospitalizations and deaths—molnupiravir has the potential to become an important tool for healthcare professionals and appropriate patients,” Dr. Dean Y. Li, president of Merck Research Laboratories, said in a statement. “We are immensely grateful to all of our collaborators, including trial patients and clinical investigators, for their important contributions to this milestone.”

This article first appeared in Contagion®.


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