Merck’s oral antiviral drug, molnupiravir, is now available FDA emergency use authorization For the treatment of mild to moderate Covid-19, this was a Thursday decision made one day after the regulatory agency authorized the use of Pfizer pills. The FDA’s action was taken when the highly contagious variant of omicron became the main strain of the novel coronavirus, which has exacerbated the increase in Covid-19 cases, thereby boosting the capacity of hospitals across the country.
Both Merck and Pfizer’s antiviral drugs work by interfering with the virus’s ability to replicate, albeit in different ways. Molnupiravir mistakenly introduced the genetic code of SARS-CoV-2, while Paxlovid targeted a key viral enzyme called the master protease. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that both drugs should work on omicron.
Cavazzoni said at a media conference on Thursday morning: “The available data we have shows that both Paxlovid and molnupiravir are effective against omicron.” “Both drugs interfere with all aspects of the virus replication device, and the device is effective It is retained in the variant.”
The authorization of Molnupiravir was obtained three weeks after the FDA advisory committee meeting on the drug, and the authorization covers its use in adults diagnosed with Covid-19, whose disease progressed to hospitalization or death The stakes are high. When other treatment options are unavailable or inappropriate, Merck drugs will be used. It can only be prescribed to people 18 years and older, because the drug affects the growth of bones and cartilage.
Authorized use Pfizer’s antiviral drug Paxlovid has expanded to pediatric patients. The FDA’s guidance states that the drug can be used to treat Covid-19 patients 12 years and older who weigh at least 40 kilograms (approximately 88 pounds). The FDA did not hold an advisory meeting for Pfizer. John Farley, director of the FDA’s Office of Infectious Diseases, said that there are no pressing scientific issues regarding Paxlovid that could benefit from discussions in the advisory committee.
Both molunupiravir and Paxlovid can only be obtained by prescription. The FDA stated that treatment with these drugs should be started as soon as possible after a positive Covid-19 diagnosis, and within five days of the onset of symptoms. These drugs are not suitable for patients who have already been hospitalized. Earlier this year, Merck stopped testing monelavir on patients who were hospitalized due to infection. Early review of Phase 2 trial data suggests that the drug is unlikely to help these patients.
Merck’s antiviral drug authorization is based on a placebo-controlled clinical trial that recruited Covid-19 non-hospitalized adults who are at high risk of developing a serious illness or hospitalization. These higher-risk patients include patients with chronic diseases or patients who have not been vaccinated or cannot be vaccinated against Covid-19. The main goal is to measure the percentage of people who were hospitalized or died for any reason within 29 days of treatment. According to the FDA, 6.8% of the 709 people treated with monoprevir in the study were hospitalized or died. In contrast, 9.7% of the 699 people who took the placebo were hospitalized or died. During the follow-up period, one patient who received morolavir died, while nine of the patients who received placebo died. The reported side effects include diarrhea, nausea and dizziness.
In clinical trials of Pfizer’s antiviral drugs, Paxlovid reduced Covid-19-related hospitalizations or deaths from any cause by 88% compared with placebo. Of the 1,039 patients who received Paxlovid, 0.8% were hospitalized or died during the 28-day follow-up period, compared with 6% of patients who received placebo.
Farley said patients should consult their doctors to determine the best treatment. Although molnupiravir is suitable for those who have no other treatment options, there are some patient groups that are not suitable for Paxlovid. Farley said examples include patients taking other drugs that may interact with Pfizer’s drugs. Paxlovid is also not recommended for patients with severe kidney problems or liver cirrhosis. The main feature of these two drugs is that they are taken orally, which allows patients to take these drugs at home. Authorized antibody therapies from Regeneron, Eli Lilly, partners Vir Biotechnology, GlaxoSmithKline, and Roche are infusions that must be performed in a clinical setting.
The patient took four pills of Merck’s molnupiravir twice a day. Patients taking Pfizer’s Paxlovid must take more pills. This medicine is taken with ritonavir, which is a medicine that slows down Paxlovid’s breakdown and helps it stay in the body longer. The Pfizer drug requires two tablets of Paxlovid and one tablet of Ritonavir, twice a day. The duration of treatment with Merck and Pfizer antiviral drugs is five days.
Photo: Christopher Occhicone/Bloomberg via Getty Images
