EU regulator okays emergency use of Merck's COVID-19 pill prior formal authorisation

Despite not formally authorising Merck pharmaceutical's COVID-19 treating pill, 'Molnupiravir', the European Medicines Agency (EMA) has issued emergency use advice for the oral medicine. The European Union (EU) regulator said that Molnupiravir can be used to treat individuals diagnosed with coronavirus who don't yet need extra oxygen and are at increased risk of developing severe symptoms. 

The EMA said in a statement that it was offering the advice “to support national authorities who may decide on a possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due to COVID-19 across the EU.”

COVID pill should be administered within 5 days of developing symptoms: EMA 

According to the statement issued by EMA, the oral medicine should be administered as soon as COVID-19 has been diagnosed and within five days of showing primary COVID symptoms, AP reported. The EMA  also recommended the pill be taken twice daily for five days. 

It should be mentioned that diarrhoea, vomiting, dizziness, and headaches are among the most prevalent side effects observed from the use of Molnupiravir, during treatment and within 14 days following the final dosage.

EMA stated that the medicine is not recommended for pregnant or nursing women and added that it has still been comprehensively evaluating the medicine.  

Notably, the antiviral oral pill would be revolutionary if it would minimise symptoms and accelerate recovery, further reducing hospital patients' inflow and assisting in preventing the pandemic in poorer nations, AP reported. 

UK first country to approve Merk's COVID pill

Molnupiravir is undergoing regulatory evaluation in the United States and other countries as well. The US Food and Drug Administration said last month that a team of independent experts will assemble in late November to examine the pill's effectiveness and safety. 

The United Kingdom became the first nation to approve Merck's COVID-19 medication previously this month. The UK's decision came at a time the COVID-19 pandemic is making a comeback in Europe. According to OurWorldInData, the EU's daily average of new instances per million people has quadrupled in recent weeks, rising from a little over 110 on October 1 to 446 on Thursday. 

Merck has stated that it would be able to create 10 million COVID treatment pills by the end of this year, but the majority of that quantity has already been acquired by governments throughout the world. 

(Image: Shutterstock/AP)