Merck asks U.S. FDA to authorize promising anti-COVID pill
WASHINGTON (AP) — Drugmaker Merck asked U.S. regulators Monday to authorize its pill against COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.
If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection.
A home-based antiviral pill could be a breakthrough, helping to ease the burden on U.S. hospital beds and reducing outbreaks in countries with poor health care systems. It would also strengthen the two-pronged approach of the pandemic: prevention and treatment with medication.
The FDA examines company data regarding the safety and effectiveness molnupiravir before making a decision.
Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.
” The value of this pill is that you don’t need to deal with infusion centers or all that stuff,” Dr. Nicholas Kartsonis from Merck’s infectious diseases unit, said. It’s an excellent tool to add to your toolbox .”
The company reported earlier this month that the pill cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. Independent medical experts who monitored the trial advised against stopping it before they could see how strong the results.
Side effects were similar for patients who took the drug as well as those who were in a group that received a placebo pill. Merck has not yet made public the specific problems that were reported. This will be an important part of the FDA s review.
U.S. officials continue to push vaccinations as the best way to protect against COVID-19. Effective drugs are crucial to preventing future outbreaks of infection, even though some 68 millions of eligible Americans refuse to get them.
Health experts have been emphasizing the importance of a simple pill since the outbreak of the pandemic. The goal is for something similar to Tamiflu, the 20-year-old flu medication that shortens the illness by a day or two and blunts the severity of symptoms like fever, cough and stuffy nose.
Three FDA-authorized antibody drugs have proved highly effective at reducing COVID-19 deaths, but they are expensive, hard to produce and require specialty equipment and health professionals to deliver.
Assuming FDA authorization has been granted, the U.S. government will purchase enough pills to treat approximately 1.7 million people at a cost of $700 per course of treatment. That’s less than half the price of the antibody drugs purchased by the U.S. government – over $2,000 per infusion – but still more expensive than many antiviral pills for other conditions.
Merck’s Kartsonis stated in an interview, that the $700 price does not reflect the final cost of the medication.
” We set the price before we had any data so that there was only one contract.” Kartsonis stated. “Obviously, we are going to be responsible and make this drug accessible to as many people as possible .”
Kenilworth: Merck, a New Jersey-based pharmaceutical company, has stated that it is currently in negotiations with governments worldwide and will use a sliding pricing scale based on each country’s economic resources. The company also signed licensing agreements with Indian generic drugmakers in order to produce low-cost versions for countries of lower income.
Several companies, including Roche and Pfizer, are also studying similar drugs. They are expected to report their findings in the coming months and weeks. AstraZeneca also seeks FDA authorization to develop a long-acting anti-bodies that can provide protection for patients with immune-system disorders who are not responding to vaccination.
Eventually some experts predict various COVID-19 therapies will be prescribed in combination to better protect against the worst effects of the virus.
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