FDA Finally Grants Patients Access to Molnupiravir

Jeffrey A. SingerYesterday the Food and Drug Administration gave emergency use authorization (EUA) to the antiviral drugPaxlovid,more than a  month after its manufacturer, Pfizer, submitted its application. This pill, if taken within the first few days of a  COVID-19 infection, has been found to be 89 percent effective in preventing progression of the disease to hospitalization. Clinical trials found no patients takingPaxlovid died from the virus.Seventy ‐​four days ago, Merck applied for an EUA for its antiviral molnupiravir. If taken in the first few days of COVID infection it is 30 percent effective in preventing hospitalization. As in thePaxlovid clinical trials, none of the patients on molnupiravir died of the virus. An FDA advisory panel recommended molnupiravir be approved on November 30, yet the FDA failed to act. Until today. This morning the FDAfinally gave America ’s patients access to the second of two antiviral drugs that snuff out COVID-19 infections including those from the omicron variant.This is good news, but as I  have mentionedbefore, U.K. regulators approved molnupiravir for British residents nearly two months ago. Had Congress enactedreciprocity legislation, wherein American patients can purchase drugs approved by regulators from other advanced countries, patients would have had access to molnupiravir since early November. How many lives could have been saved?Normally the FDA makes a  decision within a few days of receiving an opinion from its...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs