SILVER SPRING, MD. (CNN) — Advisers to the U. S. Food and Drug Administration (FDA)The U. S. government voted Thursday 16-1 in favor of Paxlovid’s full approval, saying it overcomes the drug’s threats to treat mild to moderate covid-19 in adults who are at the highest risk of severe illness, adding hospitalization and death.
Before the antiviral drug is fully approved, the FDA, which usually follows the recommendations of the independent advisory committee, will have to conduct its own review. This is expected to end in May.
More than 8 million people in the U. S. have won Paxlovid, a mixture of the drugs nirmaterlvir and ritonavir, since it became available for emergency use authorization in December 2021.
“I would say that, besides oxygen, Paxlovid has probably been the ultimate tool in this outbreak, and continues to be so,” said Dr. Richard Murphy, an infectious disease leader at the White River Junction Veterans Affairs Medical Center and a member. of the FDA’s Antimicrobial Drug Advisory Committee that voted in favor of approval at the meeting.
“We still have a lot of teams that would possibly gain advantages from using Paxlovid, adding features of unvaccinated, undervaccinated, elderly, immunocompromised and other remedies that could have significant drawbacks,” he said.
Data from phase 2 and 3 clinical trials verify Paxlovid’s efficacy regardless of the prestige of covid vaccination or past infections, the FDA said in documents released ahead of Thursday’s meeting. The firm also said it is moderate to conclude, despite limited data, that Paxlovid is “likely to retain its clinical efficacy” in high-risk adults with covid infection caused by the Omicron variant of the coronavirus, as with previous variants.
“I think the knowledge of efficacy was transparent and compelling,” said Dr. Shankar Swaminathan, leader of infectious diseases at the University of Utah School of Medicine, who voted in favor of approval Thursday. “I think the fact that the drug has retained its opposite activity to progressive strains of the virus is also reassuring and provides hope that this will continue to be the case in the future. “
The FDA also concluded that Paxlovid is not related to the Covid-19 rebound, in which other people test positive or see their symptoms return after completing the drug’s five-day treatment.
The firm said it reviewed knowledge related to bounce cases, which some users reported since Paxlovid allowed in 2021. Last year, President Biden and his former chief medical adviser, Dr. Anthony Fauci, reported symptoms of rebound after taking Paxlovid.
However, based on clinical trial data, the FDA “did not identify a clear relationship between the Paxlovid remedy and the Covid-19 rebound. “
Covid rebound rates ranged from 10% to 16%, with no difference between other people who took Paxlovid and those who gained a placebo. It is also independent of a person’s threat of severe disease with the Omicron variant compared to the Delta variant, to the knowledge of FDA-reviewed clinical trials.
Overall, the company said, the findings imply that COVID-19 rebound could occur in a subset of infections as part of the natural progression and solution of the disease.
There were no known primary protection issues in clinical trial data, the FDA said. However, the firm has reported on 137 drug interactions (DDI) of Paxlovid that can cause serious adverse effects.
Paxlovid can save you the framework of metabolizing certain drugs, resulting in higher concentrations of drugs that can cause serious or life-threatening reactions, according to an FDA Emergency Use Authorization fact sheet. Medications not taken with Paxlovid come with certain medications to treat situations such as high cholesterol, gout, migraine, abnormal heartbeat, and benign prostatic hyperplasia.
According to the agency, more than 50% of patients eligible for Paxlovid can take DDI medications at the time of covid diagnosis.
“I would like to emphasize that we emphasize the importance of threat mitigation for prescribers, number one care physicians and other prescribers in terms of drug interactions,” said FDA committee member Dr. David Hardy, an assistant clinical professor at the Keck School. University of Southern California Medicine, which voted in favor of approval. “That’s where I think we might have problems, or I can tell where they might have problems, prescribing this drug without a clever wisdom of what ritonavir does. “to other drugs. “
The committee said the benefits of Paxlovid may not outweigh the risk of adverse drug reactions in all patients. For others at higher risk for severe COVID-19, IDDs can be controlled by withholding the medication, adjusting the dose, or expanding follow-up.
Clinical trials of the protection and effectiveness of Paxlovid in children, pregnant women and others with weakened immune systems are ongoing.
El-CNN-Wire™