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The European Union’s medicines watchdog has greenlit Merck's anti-COVID pill to be used in emergencies as the region faces a deluge of new COVID-19 infections and multiple countries implement new lockdown measures.
On Friday, the European Medicine Agency (EMA) announced that the pill — known as molnupiravir, Lagevrio, or MK 4482 — can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19.
The antiviral pill inhibits the replication of certain RNA viruses. The treatment, which involves taking two capsules daily for five days, works best at the early stages of the illness, so the EMA says it should be given as soon as possible after a diagnosis of COVID-19 and within five days of the start of symptoms.
Early trial data published last month showed that the molnupiravir treatment halves death and hospitalization risk in patients. The trial saw 385 high-risk COVID-19 patients receive two daily doses of the drug and another 377 receive a placebo. After one month, 7.3 percent of the patients that took molnupiravir were hospitalized, compared to 14.1 in the placebo group. No deaths were reported in the group that received the treatment, but eight deaths were reported in the placebo group.
The EMA said it reviewed this data and felt the need to authorize the drug “in light of rising rates of infection and deaths due to COVID-19 across the EU.” A handful of countries in the EU, such as Germany and Austria, are currently experiencing sky-rocketing rates of COVID-19 as they enter the colder months. The situation has become so severe in Austria, it issued a full lockdown as of Monday while making vaccines compulsory from February next year.
The UK became the first country in the world to approve molnupiravir on November 4. In June, the US committed to buying $1.2 billion worth of molnupiravir (around 1.7 million courses) from Merck, provided it received approval from the US Food and Drug Administration.
Meanwhile, the EU also announced on Friday it will start to review data on Paxlovid, a "rival" anti-COVID pill developed by Pfizer. Early data suggest using this pill to treat high-risk people with COVID-19 cuts the risk of hospitalization or death by 89 percent.
“While a more comprehensive rolling review is anticipated to start ahead of a possible application for a marketing authorisation, this current review will provide EU-wide recommendations in the shortest possible timeframe so they can be used by national authorities who wish to take evidence-based decisions on the early use of the medicine,” said the EMA.
