When will oral medication therapy be available for the management of COVID-19?

The United States Food and Drug Administration (FDA) may authorize unapproved medical products in an emergency under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when supported by the Secretary of the U.S. Department of Health and Human Services (HHS). With HHS support to issue Emergency Use Authorizations (EUAs), the FDA carefully evaluates available data to make medical products available more quickly (e.g., during a pandemic), as opposed to waiting for all the evidence that would normally be needed for full FDA approval. The Public Readiness and Emergency Preparedness Act (PREP Act) provided liability immunity for medical countermeasures against COVID-19, including support of emergency use authorizations as documented in the Federal Register.

An article from the Journal Nature Structural & Molecular Biology describes the mechanism of action of an oral antiviral medication, Molnupiravir by stating that it “[i]ncreases the frequency of viral RNA mutations and impairs SARS-CoV-2 replication in animal models and in humans.” See Nat Struct Mol Biol. 2021 Sep;28(9):740-746. doi: 10.1038/s41594-021-00651-0. Epub 2021 Aug 11.

The active form of the medication causes the virus to mutate, which ultimately impairs viral replication and activity. Phase III trials sponsored by Merck Sharp & Dohme Corp. are comparing oral Molnupiravir taken twice daily to placebo in the ability to reduce hospitalizations and death due to COVID-19 in non-hospitalized patients. Merck is seeking Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), and the United States government has agreed to purchase millions of doses if the FDA authorization comes through.

Molnupiravir, touted to prevent COVID-19 disease progression, may be available in late 2021 through Emergency Use Authorization by the FDA. Clinical trial data on Molnupiravir can be found at the National Institutes of Health site and developments on FDA Emergency Use Authorization can be found at FDA.gov.

Pacific Apex Law Group’s Health Care and Life Sciences practice group includes law partners Julie McCoy, a clinical pharmacist, and Katie Spear, an optometrist. Julie and Katie have extensive backgrounds and experience in clinical studies and institutional review board initiatives, as well as FDA regulation related to pharmaceuticals and medical devices.

Do you have questions about vaccines or need assistance getting your product to the market? We are happy to help you with regulatory compliance, production, distribution, and use of pharmaceuticals, biotech products, and medical devices. Call us today to schedule your complimentary consultation at (888) 609-8718.