Monday, January 17, 2022

FDA weighing emergency approval for 1st pill to treat COVID-19

October 11 (NWN) – On Monday, pharmaceutical giant Merck asked US regulators to approve an antiviral pill that will be the first pill in the US to be approved for the treatment of COVID-19.

The company said it has applied to the FDA for an emergency use of its drug molnupiravir for the treatment of coronavirus disease in adults in the United States. Merck has developed the drug in partnership with Ridgeback Biotherapeutics.

If approved, the pill would be the first antiviral pill approved at any level in the United States for the treatment of COVID-19.

Other FDA-approved treatments are given by injection or intravenous injection.

Merck said molnupiravir will be a significant step forward in the fight against the pandemic, as it will treat COVID-19 at home and at a significantly lower cost than other treatments.

Earlier this month, Merck said it would seek permission for emergency treatment after clinical trials showed molnupiravir cut coronavirus-related hospitalizations by nearly 50%.

“The extreme impact of this pandemic requires us to act with unprecedented urgency, and that is exactly what our teams have done by submitting a request for lightnupiravir to the FDA,” Merck CEO Robert Davis said in a statement.

“The FDA filing is an important step towards making molnupiravir available to people who can benefit from an oral antiviral drug that can be taken at home,” added Wendy Holman, CEO of Ridgeback Biotherapeutics.

The COVID-19 pills will add a weapon against the pandemic and possibly offer a new line of defense for the tens of millions of Americans who have so far refused the coronavirus vaccine.

The FDA is expected to make a decision on lolnupiravir within a couple of weeks. The agency will weigh the companies’ data on the drug’s efficacy, safety and side effects.

An emergency use authorization allows for the widespread distribution of a specific drug during a public health emergency prior to the completion of all clinical trials. To be approved, the FDA must determine that the proven or potential benefits of a drug outweigh the known and potential risks.

Nation World News Desk
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