The Ministry of Health has notified the company Merck Sharp & Dohme Corp of the emergency use authorization for the drug Molnupiravir 200 mg capsules, which enables the company to sell it nationwide in Costa Rica.
The Ministry of Health released a statement saying “Molnupiravir is indicated for the treatment of mild to moderate COVID-19 disease in adults with positive direct viral test results for SARS-CoV-2 and who are at high risk of progression to severe COVID-19, including hospitalizations. or death.
The use authorization is provided based on the Administrative Resolution MS-DM-RM-1363-2022 published on January 24 of this year, which establishes the requirements to obtain an Authorization for the Use and Import of medicines to treat Covid-19, based on the recognition of the Marketing Authorization or Emergency Use Authorization of Strict Regulatory Authorities or of medicines recommended by the World Health Organization.
As part of the authorization, Merck Sharp & Dohme Corp must maintain records of the distribution of the medicine (ie, lot numbers, quantity, date and destination), as well as submit monthly reports of possible adverse or safety events.
The Ministry of Health says it has no relationship with the import times of the medicine, nor with the prices that it will have in the country.
Nonetheless, according to a Yale Medicine finding: An early report showed the Merck drug cut the risk of hospitalization and death to 50% in patients who had mild-to-moderate disease, but a final analysis of the trial reported on in November, before the FDA authorization, showed a reduction in that benefit to 30%.
Meanwhile Pfizer reported that its pill (combined with a low dose of ritonavir, an HIV drug) showed 89% efficacy in preventing hospitalization and death in the high-risk patients it studied.
So far, treatments for COVID-19 have been hard to deliver or not very effective. “We don’t have a lot of COVID medications in our arsenal,” Dr. Shaw of Yale medicine says. Remdesivir, the only COVID-19 drug treatment fully approved by the FDA, can only be administered intravenously in the hospital.
It’s also only for those ages 12 and older, regardless of how severe their symptoms are, and studies suggest it may provide only modest benefit. The Merck and Pfizer pills are the first drugs that can be taken at home, early enough to prevent hospitalization.
“Hopefully, there will be more tools to help us better treat our COVID patients,” Dr. Shaw says.
According to experts, one would need to know they are Covid positive and acquire the medication before they progressed beyond mild-to-moderate illness.