The UK’s medical regulator approved on Thursday the first oral pill treating COVID-19 developed by U.S.-based pharmaceutical companies Merck, Sharp and Dohme, and Ridgeback Biotherapeutics, with the government ordering 480,000 courses due for delivery in November.
The pill, called Molnupiravir, will be administered to those recently diagnosed with the virus twice a day. The pill is the first antiviral medication for COVID-19 that could be taken orally rather than through injection or intravenously.
“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,” British Health Secretary Sajid Javid in a statement, labelling the approval as a “gamechanger,” for vulnerable people.
According to the UK Government, the pill will be administered to both vaccinated and unvaccinated people following a national study meant to gather further data determining its level of effectiveness before making it publicly available.
It is worth noting, that for the drug to be most effective, it needs to be taken within five days of developing symptoms.
The distribution process by the NHS remains unclear moving forward, with analysts noting that a handful of care homes will be the first to receive the drug, while elderly or vulnerable patients may need to receive a prescription from their doctors after testing positive.
“Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission,” Merck said in a statement.
The Medicines and Healthcare Products Regulatory Agency (MHRA) categorized the drug as safe and effective at reducing hospitalization and death in people experiencing mild to moderate COVID-19 symptoms but are still likely of developing severe illness.
The watchdog’s head June Raine hailed the pill as “another therapeutic to add to our armory against COVID-19.”
“It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage,” she said in a separate statement.
The trial phase evaluated data from 775 patients initially enrolled in the third phase of testing and had recently been diagnosed with the disease.
“Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. All patients were required to have at least one risk factor associated with poor disease outcome at study entry,” Merck highlighted in it’s clinical trials.
According to the report, 7.3 percent of those who took the drug were hospitalized that compares with 14.1 percent of patients who were given a placebo. “There were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of COVID,” it added.
In its approval document, the MHRA recommends the drug is used “as soon as possible” following a positive COVID test and within five days of symptoms onset.
It is worth mentioning that the British government has failed to disclose the cost of the 480,000 courses of molnupiravir; however, the U.S. has already ordered an advance purchase of 1.7 million courses for a fee of roughly $1.2 billion, allowing for roughly $700 for each patient.
Other countries including Australia, Singapore and South Korea have also made purchase agreements.