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U.S. FDA panel to weigh Merck’s COVID-19 antiviral drug -Breaking

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© Reuters. FILE PHOTO: An experimental COVID-19 treatment pill, called molnupiravir and being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters on October 26, 2021.

By Manas Mishra

(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration will vote later on Tuesday on whether to recommend authorization of Merck & Co’s antiviral pill to treat COVID-19.

U.S. drugmaker, Eli Lilly and Company reported that its oral medicine had a 30% drop in effectiveness for reducing death rates. The data was based on over 1400 patient records from the late-stage research. The company had previously reported a reduction of 50% using data from 775 patients.

Analysts stated that they expect the drug will be approved as Merck’s Molnupiravir (developed with Ridgeback Biotherapeutics) and others. Pfizer Paxlovid and (NYSE) are expected to soon be important therapeutic tools which can be used at home for COVID-19-related symptoms.

Rival oral treatments target portions of the virus not affected by the Omicron mutations. If the variant is able to threaten natural immunity and vaccine-induced immunity, they could prove even more critical.

Merck tablets should be consumed twice daily for the first five days after the onset of symptoms.

Briefing materials posted by the FDA before the meeting were available indicated that they did not have a recommendation for the approval of the drug. However, staff members of FDA stated that they will present their assessments of the data during the meeting.

The panel was asked to address concerns about whether the drug might cause the virus’ mutation and to determine if the medication should be given to a larger population.

In animal studies, birth defects have been shown to be linked with drugs of the same type as molnupiravir. Merck claims that similar tests of molnupiravir in animals – at longer doses and for higher amounts than humans – have shown the drug doesn’t affect mammalian genome.

Vamil divan, Mizuho analyst said: “We expect significant discussion about Molnupiravir’s mechanisms of action and theoretical safety issues, particularly related to possible birth defects from this drug and whether or not the drug should be allowed in pregnant women and women of childbearing years.”

Divan indicated that Pfizer may sign more deals with other countries for its drug. The combination of ritonavir (an antiviral) and the Pfizer drug showed a 89% drop in deaths and hospitalizations in trials.

Pfizer, just like Merck, was able to stop its trial early because of its high success rate.

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