Portland, Oregon 2021-11-30 17:30:37 –
((((Hill) – The Food and Drug Administration (FDA) advisory group has decided to recommend Merck’s COVID-19 antivirals to infected adults at high risk of severe coronavirus disease, hospitalization, or death. ..
The panel narrowly approved Merck’s five-day oral treatment with 13-10 votes on Tuesday.
Advisors recommend that the FDA approve pills developed with Ridgeback Biotherapeutics for adult patients who tolerate mild to moderate COVID-19, who are at high risk of serious illness due to underlying health conditions, etc. bottom.
Approval of these tablets may increase accessibility with COVID-19 treatment at home, awaiting FDA and Centers for Disease Control and Prevention (CDC) approval. The United States has already agreed to buy 3.1 million courses of medicine, and you can buy more.
Antiviral COVID-19 drugs have been regarded as a potential game changer in a pandemic, as all current drugs require injections or IVs. Other tablets are under development, including Pfizer’s Paxlovid, which requested FDA approval earlier this month.
Voting takes place after the FDA Publish a review Merck’s data on the drug last week, which concluded the efficacy of molnupiravir but raised concerns about its effects on pregnant people.
Merck representatives recommended during the meeting that pregnant or lactating people should not take pills due to potential risks such as toxicity and possible birth defects.
The drug company has suggested that women of childbearing age use contraception while taking molnupiravir. Merck will launch a pregnancy monitoring program to further track the effects of the drug on pregnant people.
Merck is not currently seeking permission to administer pills to children.
Some experts have expressed concern that drugs that insert a small error in the virus’s genetic code to prevent replication could mutate the virus into a more dangerous strain, but the FDA has addressed the issue. We consider it a “theoretical” concern.
A pharmaceutical company applied for an emergency use authorization last month after studies suggest that molnupiravir reduces the risk of hospitalization by 50%. However, updated data from Friday showed a 30 percent reduction in hospitalization among more participants.
Merck pills do not serve as a prophylactic treatment because they are given to individuals who are already infected to avoid worse consequences.
This treatment is not designed to replace vaccination, as the COVID-19 vaccine is still needed to stop the infection in the first place. Merck did not study the effects of the drug among vaccinated people.
The advisor’s decision also occurs when anxiety rises to the Omicron strain, a variant of the World Health Organization’s latest concern.
Merck representatives told the FDA at the meeting that the company has not tested molnupiravir against the Omicron variant, but hopes that the pill will continue to be effective against this strain.
FDA advisers narrowly endorse Merck’s COVID-19 antiviral pill Source link FDA advisers narrowly endorse Merck’s COVID-19 antiviral pill