Merck asks EU regulator to authorize its COVID-19 pills
Amsterdam The European Medicines Agency said it had received an application from Merck to license the anti-coronavirus, the first pill that appeared to treat COVID-19.
In a statement on Tuesday, the European Union’s drug regulator said it had begun evaluating molnopiravir, which was provided by Merck and Ridgeback Biotherapeutics, and that a decision could be made within weeks on whether it could be filtered.
Last week, the EMA issued emergency advice saying that molonoperavir could be used to treat adults with coronavirus who do not yet need additional oxygen and are at higher risk of becoming seriously ill.
The agency said the drug should be given as soon as possible after COVID-19 is diagnosed and within five days of symptoms starting. It is intended to be taken twice a day for five days.
Earlier this month, Britain became the first country in the world to approve the drug. The UK has licensed molnopiravir for adults who have been diagnosed with COVID-19 and have at least one risk factor for severe disease.
Antiviral pills that reduce symptoms and speed recovery could prove groundbreaking, reducing the caseload on hospitals and helping reduce explosive outbreaks in conjunction with vaccination campaigns.
Europe is now at the epicenter of the pandemic and the World Health Organization has warned that without urgent measures, Europe could see an additional 700,000 deaths from COVID-19 by spring.
Molnupiravir is also awaiting a review with US regulators, which is expected to convene an expert panel later this month to consider authorization.
Even if the pill is licensed, initial supplies will be limited. Merck said it could produce 10 million courses of treatment this year, but much of that supply has already been purchased by governments around the world.
In October, Merck agreed to allow other drug companies to produce molnopiravir and signed a licensing agreement with the United Nations-backed Medicines Patent Group, allowing the pills to be made by companies in dozens of countries.
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