Merck, a drugmaker, asked U.S. regulators Monday for authorization to its COVID-19 pill. This would be an entirely new and simple-to-use tool to fight the pandemic.
It would be the first drug to treat COVID-19 if it is approved by the Food and Drug Administration. This decision could take as little as a few weeks. All FDA-approved treatments for the disease require injections or IVs.
A home-based antiviral pill could be a breakthrough. It could reduce the burden on U.S. hospital beds and help to prevent outbreaks in countries with poor health care systems. It would also strengthen the two-pronged approach of the pandemic: prevention and treatment with medication.
Before making a decision, the FDA will review data from companies on the safety and efficacy of the drug, Molnupiravir.
Merck and Ridgeback Biotherapeutic, Ridgeback’s partner, said that they asked the agency for emergency treatment for people with mild-to moderate COVID-19 who are at high risk of severe illness or hospitalization. This is the same way COVID-19 Infusion Drugs are used.
“The benefit is that it’s a tablet so you don’t need to deal with infusion centers or all the factors around that,” Dr. Nicholas Kartsonis, senior vice president at Merck’s infectious diseases unit, said. It’s an excellent tool to have in your toolbox.
The company earlier reported that the pill had reduced hospitalizations and death by half for patients suffering from COVID-19. Independent medical experts who monitored the trial advised against stopping it at an early stage.
Side effects were similar for patients who took the drug and those who took a dummy pill. Merck has not made public the specific problems that were reported to FDA, but this will be an important part of FDA’s review.
Top U.S. officials in health continue to promote vaccinations as the best protection against COVID-19.
Dr. Anthony Fauci stated that it was better to prevent you from becoming infected than to have an infection. He spoke out while speaking about Merck’s drug.
Yet, 68 million Americans are still not vaccinated. This underscores the importance of effective drugs to prevent future outbreaks.
Health experts have been emphasizing the importance of a simple pill since the outbreak of the pandemic. It is hoped that something will be similar to Tamiflu (20-year-old flu medication) which reduces symptoms such as fever, cough, and stuffy nose.
Three FDA-approved antibody drugs have been proven to be highly effective in reducing COVID-19 death rates. However, they are costly and difficult to produce. They also require special equipment and the expertise of health professionals to deliver.
The U.S. government has accepted FDA approval to purchase enough pills to treat approximately 1.7 million people at a cost of $700 per course. This is less than half of the cost of antibody drugs purchased by U.S. government, which are more than $2,000 per infusion. However, it’s still much more expensive than antiviral pills for other conditions.
Merck’s Kartsonis stated in an interview that $700 is not the final price of the medication.
Kartsonis stated that the price was set before any data existed, which is why there is only one contract. “Obviously, we are going to be responsible and make this drug available to as many people as possible around the globe.
Merck, based in Kenilworth, New Jersey, 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 several Indian generic drugmakers in order to produce low-cost versions for countries of lower income.
Pfizer and Roche are also studying similar drugs. They are expected to report their findings in the coming weeks or months. AstraZeneca has also applied for FDA approval for a long-acting anti-bodicle drug that will provide protection for patients with immune-system disorders who are not responding to vaccination.
Experts predict that COVID-19 treatments will eventually be combined to protect against the worst side effects.