- By Deb Balzer
COVID-19 pill gets advisory panel approval
The first oral antiviral medication to treat COVID-19 is one step closer. A Food and Drug Administration (FDA) advisory panel has voted to recommend emergency use authorization for molnupiravir. This drug, which is manufactured by Merck & Co Inc., treats mild to moderate COVID-19 infection in adults at risk for progressing to severe COVID-19 infection or hospitalization. Next, the recommendation goes to the FDA for a decision.
Pfizer Inc. also has an antiviral oral pill that the company hopes will soon be available for outpatients. It will submit data to the FDA for Paxlovid, a drug to help mild to moderate COVID-19 infection in high-risk patients.
"If and when one or both of these drugs is approved, that's going to change the way we treat COVID-19 infection for outpatients," says Dr. Andrew Badley, a Mayo Clinic infectious diseases physician.
Journalists: Broadcast-quality soundbites are available in the downloads at the bottom of the post. Please courtesy: "Andrew Badley, M.D./Infectious Diseases/Mayo Clinic."
Dr. Badley says medical experts are beginning to get an arsenal of medications to treat COVID-19 patients.
"Hopefully soon we'll have these oral antivirals. We need to learn which one if any is better; which one to use; where, when and why; what the side effects are. There are some concerns related to how each drug works that may favor the use of one drug in certain situations. Also, we need to learn whether the SARS-CoV2 virus (the virus that causes COVID-19) can become resistant to these drugs. We have a number of drugs: monoclonal antibodies, remdesivir, steroids and some immune-modifying drugs that we can use in the hospitalized setting. We are beginning to understand how they work in combination and how to sequence them. The FDA advisory panel recommendation today begins a similar discussion for outpatient treatment options. Having a number of options is good news for patients and for health care providers, and reflects unparalleled efforts in drug discovery that have gotten us to this remarkable point in less than two years."
Dr. Badley says COVID-19 prevention remains the most effective strategy, including vaccination, boosters, masking in public, along with early diagnosis and treatment.
For the safety of its patients, staff and visitors, Mayo Clinic has strict masking policies in place. Anyone shown without a mask was recorded prior to COVID-19 or recorded in an area not designated for patient care, where social distancing and other safety protocols were followed.
Information in this post was accurate at the time of its posting. Due to the fluid nature of the COVID-19 pandemic, scientific understanding, along with guidelines and recommendations, may have changed since the original publication date.
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