Merck Asks FDA For Emergency Authorization For Its Covid Pill

Bloomberg: Merck Seeks Emergency Use Authorization For Pill For Covid 
Merck & Co. and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the U.S. for molnupiravir, moving the pill closer to becoming the first oral antiviral treatment for Covid-19.An application was submitted with the Food and Drug Administration for molnupiravir to treat mild-to-moderate Covid-19 in adults at risk of developing a severe illness that may require hospitalization, the companies said in a statement Monday. Submissions to regulatory authorities worldwide are expected in the coming months after interim analysis of clinical trial data found that it cut the risk of hospitalization for such patients by half. (Gale and Griffin, 10/11)

The New York Times: Merck Applies For Emergency Approval For What Would Be The First Pill To Treat Covid
Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid. An approval for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used. (Robbins, 10/11)

Nature: How Antiviral Pill Molnupiravir Shot Ahead In The COVID Drug Hunt
The pharmaceutical firm Merck announced last week that an antiviral pill it’s developing can cut hospitalizations and deaths among people with COVID-19 by half. The results haven’t yet been peer reviewed. But if the drug candidate, molnupiravir, is authorized by regulators, it would be the first oral antiviral treatment for COVID-19. By contrast, the other currently authorized drugs must be delivered intravenously or injected. A pill could make treating patients earlier on in their infection much easier — and more effective. It could also keep hospitals from overflowing, especially in places where vaccination rates are still low, such as many low- and lower-middle-income countries. Molnupiravir was so effective in a phase 3 trial involving COVID-19-positive people at risk of severe illness that clinicians halted enrolment early. (Willyard, 10/8)

The Wall Street Journal: Who Slowed Merck’s Covid Remedy?
When Merck and Ridgeback Biotherapeutics announced on Oct. 1 that their new antiviral pill reduced Covid hospitalizations by roughly half, some in the media blamed Donald Trump. An Axios headline: “Before Merck backed COVID antiviral, Trump admin turned it down.” In fact, Trump officials pushed for government funding to accelerate the development of the drug, molnupiravir. They were opposed by a career official, Rick Bright, whom Democrats praised as a “whistleblower.” Mr. Bright joined the Biomedical Advanced Research and Development Authority in 2010 and became Barda’s director in 2016. The authority, part of the Health and Human Services Department, is charged with preparing for and responding to public-health threats. After Mr. Bright repeatedly clashed with HHS officials, he was reassigned in April 2020 to a lower-level job at the National Institutes of Health. Mr. Bright then filed a complaint accusing Trump officials of pressuring him to fast-track unsafe drugs and award contracts “based on political connections and cronyism.” (Finley, 10/10)

Reuters: Two Indian Drugmakers To End Trials Of Generic Merck Pill For Moderate COVID-19
Two Indian drugmakers have requested permission to end late-stage trials of their generic versions of Merck & Co's (MRK.N) promising experimental oral antiviral drug molnupiravir to treat moderate COVID-19, a week after Merck said its own trial had succeeded for mild-to-moderate patients. Merck earlier this year suspended its own development of molnupiravir as a treatment for hospitalized COVID-19 patients since many of them have reached a phase of the disease that is too late for an antiviral drug to provide much help. The Indian companies - Aurobindo Pharma Ltd (ARBN.NS) and MSN Laboratories - did not exclude hospitalized patients in designing their moderate COVID-19 trials, according to study documents, although it was not known if the trials ultimately included people in the hospital. (Singh, Kumar Mitra and Arora, 10/8)

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Reuters: AstraZeneca Drug Cocktail Succeeds In Late-Stage Study To Treat COVID-19
AstraZeneca's experimental COVID-19 antibody drug cocktail succeeded in reducing severe disease or death in non-hospitalised patients in a late-stage study, the British drugmaker said on Monday. The drug, called AZD7442, reduced the risk of developing severe COVID-19 or death by 50% in patients who had been symptomatic for seven days or less, meeting the main goal of the trial. (10/11)