Fri. Mar 29th, 2024
Source: Time

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) on Thursday granted a conditional authorization to Merck’s coronavirus antiviral, the first pill shown to successfully treat COVID-19. The antiviral medication molnupiravir will be used for the treatment of mild-to-moderate Covid-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness.

The MHRA recommended the use of the Covid-19 drug molnupiravir as soon as possible following a positive Covid-19 test and within five days of symptoms onset.

It said based on clinical trial data, the drug is found to be most effective when taken during the early stages of the infection.

Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), Lagevrio (molnupiravir) works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and, therefore, reducing the severity of the disease.

Countries with weak medical infrastructure and reduced vaccination awareness will healthily benefit from the antiviral pill, reducing the burden on the hospitals and other medical institutions. The pill would not just work on the reduction of symptoms but also speed the recovery of the patient. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.

The authorisation is based on positive results from a planned interim analysis from a phase-3 clinical trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalised, unvaccinated adult patients with laboratory-confirmed mild-to-moderate Covid-19, symptom onset within five days of study randomisation and at least one risk factor associated with poor disease outcomes.

Molnupiravir is pending review at regulators in the U.S., Europe and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.
“Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19,” said Britain’s health secretary, Sajid Javid.

“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” he said in a statement, referring to the U.K.’s National Health Service. Doctors said the treatment would be particularly significant for people who do not respond well to vaccination.

Initial supplies will be limited. Merck has said it can produce 10 million treatment courses through the end of the year, but much of that supply has already been purchased by governments worldwide.

In October, U.K. officials announced they secured 480,000 courses of molnupiravir and expected thousands of vulnerable Britons to have access to the treatment this winter via a national study.

 

MSD previously announced that it had entered into a licensing agreement with the medicines patent pool to increase broad access to molnupiravir in low- and middle-income countries.

“It also has non-exclusive voluntary licensing agreements with established Indian generic manufacturers to accelerate availability of the drug in more than 100 low- and middle-income countries following approvals or emergency authorisation by local regulatory agencies,” the company had said.

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