Merck & Co. Inc. said on Monday it has applied for U.S. emergency use authorization for its tablet to treat patients with mild-to-moderate cases of COVID-19, putting it on course to become the first oral antiviral medication for the disease.
Its authorization could help change clinical management of COVID-19 as the pill can be taken at home. The treatment, molnupiravir, could halve the chances of death or being hospitalized for those most at risk of contracting severe COVID-19, according to the drugmaker.
Viral sequencing done so far has shown it is effective against all coronavirus variants, including delta, Merck said.
The interim efficacy data on the drug, which has been developed with Ridgeback Biotherapeutics, had heavily impacted the shares of COVID-19 vacine makers when it was released last week.
Existing drugs include Gilead Sciences Inc.’s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.
Meanwhile, monoclonal antibody drugs from Regeneron Pharmaceuticals Inc. and Eli Lilly have so far seen only limited uptake due to the difficulty in administering them.
In India, however, two drugmakers had last week sought to end late-stage trials of their generic versions of molnupiravir to treat moderate COVID-19, according to study documents.
A source with the Drug Controller General of India had said the pill has not shown “significant efficacy” against moderate cases, but was successful against mild cases.
Merck said its trials are based on U.S. Food and Drug Administration definitions, which for moderate COVID-19 describe blood oxygen levels as no lower than 93 per cent, whereas the trials in India define moderate as blood oxygen levels between 90 and 93 per cent.
What’s happening across Canada
What’s happening around the world
As of Monday morning, more than 237.8 million cases of COVID-19 had been reported worldwide, according to Johns Hopkins University’s coronavirus-tracking tool. The reported global death toll stood at more than 4.8 million.
In Europe, Russia reported 957 coronavirus-related deaths on Monday, close to the all-time high of 968 reported two days earlier. The government coronavirus task force also said it had recorded 29,409 new cases in the last 24 hours.
Moscow, which reported 5,002 cases on Monday, said it was launching free “express” antibody-based tests for COVID-19 at a number of locations, including shopping malls, in an attempt to avert a new wave of restrictions.
In the Asia-Pacific region, Sydney hairdressers, gyms, cafes and bars reopened to fully vaccinated customers on Monday for the first time in more than 100 days after Australia’s largest city achieved a vaccination benchmark.
Sydney had planned to reopen after 70 per cent of the New South Wales state population aged 16 and older were fully vaccinated. By Monday, 73.5 per cent of the target population was fully vaccinated and more than 90 per cent have received at least one dose.
New Zealand will require teachers and workers in the health and disability sectors to be fully vaccinated, Prime Minister Jacinda Ardern said, as she extended restrictions in Auckland for another week.
In the Americas, Venezuela on Sunday received a second batch of 2.5 million doses of COVID-19 vaccines via the COVAX mechanism, while the government said it hoped to reach immunity for 70 per cent of Venezuelans by the end of the month.
In Africa, Egypt’s public prosecution said on Sunday it had ordered the arrest of three people after thousands of unused COVID-19 vaccines were found dumped along a water channel.