FDA Grants Emergency Authorization to COVID-19 Pill Molnupiravir

The oral antiviral therapy proceeds the first indication for the drug class by just a day; the US will now have multiple pills to treat COVID-19.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to a second antiviral pill for the treatment of COVID-19.

Merck and Ridgeback Biotherapeutics’ molnupiravir has been granted EUA just 1 day after Pfizer’s nirmatrelvir and ritonavir tablet therapy (Paxlovir) became the very first available oral treatment for patients with COVID-19.

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.

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.”