EU DRUG AGENCY GIVE GREEN LIGHT FOR TWO NEW COVID-19 THERAPEUTICS

Fri 12 November 2021:

The European Medicines Agency (EMA) has issued a favourable opinion on two drugs for COVID-19 – Ronapreve and Regkirona – which the Commission identifies as promising in the context of the EU Coronavirus treatment strategy. These are drugs that can be taken in the early stages of infection and are based on antiviral monoclonal antibodies.

Welcoming this important progress in the framework of the Strategy, the Commissioner for Health and Food Safety Stella Kyriakides stressed that “with COVID-19 infections increasing in almost all Member States, it is reassuring to see promising treatments developing as part of our coronavirus treatment strategy. Today we are taking an important step forward towards our goal of approving up to five new medicines in the EU by the end of the year.”

Kyriakides underlined that “vaccination remains the main tool for the fight against COVID-19, protection against infections, hospitalisation, loss of life and long-term consequences of illness. While the EU has one of the highest vaccination rates in the world, people will continue to get sick and need safe and effective treatments to fight the infection and improve the outlook not only for faster recovery but also for survival.”

“As part of our treatment strategy, we also support Member States to have access to new medicines through our joint procurement in the EU. Two supply agreements have already been concluded so far and negotiations are under way for more treatments for COVID-19 under evaluation by the EMA “, she added.

She concluded that the EMA is currently evaluating six other drugs that could be approved soon, provided that the final data show their quality, safety, and effectiveness. “This rapid progress in our ambitious treatment strategy shows what a strong European Health Union can offer.” Finally, the Health Commissioner stressed that “vaccination is the only preventive way out of the crisis.”

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