Brussels (Brussels Morning) The European Medicines Agency (EMA) is ready to provide guidance to EU countries on the emergency use of the first new COVID-19 pill developed by Merck & Co.
The EU’s medicine regulator still needs to approve the new drug, molnupiravor, and it is not yet clear when the final market authorisation will be granted. “We will try to speed up our assessment in order to reach an authorisation as soon as possible“, EMA’s head of vaccine strategy Marco Cavaleri told a news conference.
In the meantime, EMA is encouraging national governments to request the drug in critical situations: “We are ready to give advice to EU member states so that they can make this new treatment available for emergency use, ahead of a marketing authorisation”, the EMA stated on social media.
Data from clinical trials on the new antiviral show a 50% reduction in the risk of death and hospitalisation, according to the EU’s watchdog.
UK greenlights new pill
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Merck’s new pill on November 4. The MHRA said the pill is “safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19”.
“This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment”, UK Health Secretary Sajid Javid declared.
Merck’s pill is to be commercially launched under the name Lagevrio in the UK, which announced last month that it had managed to secure 480,000 courses of the drug.
“Vaccines have already done so much to help break the link between infections and hospitalisations. Antivirals are another line of defence for the most clinically vulnerable and patients who are seriously ill with COVID-19”, Richard Torbett, the Chief Executive of the Association of the British Pharmaceutical Industry, said.
Surge in COVID-19 cases
According to the regional office of the World Health Organization (WHO), the European region is once again the “epicentre of the pandemic”, with health systems facing a “real threat” of COVID-19 resurgence or already fighting it.
The transmission rate in the region is of “grave concern”, as cases near-record levels, WHO’s chief for Europe, Hans Kluge, told a media briefing yesterday.“If we stay on this trajectory, we could see another half a million COVID-19 deaths in Europe and Central Asia by the February 1 next year”, he warned.