Ronapreve, Regkirona: what we know about the two treatments approved by the EMA

While Merck's pill regularly makes headlines, two other treatments steal the show.

The European Medicines Agency (EMA) said Thursday, November 11 in a press release that it had approved the use of a treatment from the Swiss pharmaceutical company Roche, Ronapreve, and a treatment from the South Korean company Celltrion, the Regkirona (regdanvimab).

What do we know about them?

Developed by the Swiss laboratory Roche, Ronapreve is already known in France.

Since the beginning of August, immunocompromised people can benefit from an "early access authorization" to this serum.

However, it has one drawback: its high price, estimated at around 1,700 euros per dose.

Regkirona or Regdanvimab from biotech Celltrion, on the other hand, has been relatively discreet so far but is already marketed in South Korea.

"Phase III is over, the results are very good, we are in permanent discussion with the European Medicines Agency (EMA)", rejoiced at the end of August, Salim Benkhalifa, medical director France at Celltrion, in the HuffPost.

Read also Ronapreve, Molnupiravir, AZD7442 ... where are the treatments against Covid?

According to the regulator, these are the first drugs against Covid-19 based on monoclonal antibodies to receive a positive opinion.

This type of treatment seeks to select natural antibodies and to reproduce them artificially in order to then administer them as treatment, by intravenous infusion.

Who are they for?

"The Committee recommended that Ronapreve be authorized in adults and adolescents (from 12 years of age and weighing less than 40 kg) who do not need additional oxygen and who are at risk of developing a severe form" , specifies the European Medicines Agency.

Regarding Regkirona, the regulator recommends its authorization for adults positive for Covid only, meeting the same criteria.

Ronapreve can also be given to uninfected people 12 years of age and over, weighing more than 40 kg, for prevention.

What does this approval mean?

“Today, we are taking an important step towards our goal of authorizing up to five new treatments in the EU by the end of the year,” said Stella Kyriakides, European Commissioner for Health. , adding that it was "reassuring to see many promising treatments in development as part of our therapeutic strategy against Covid-19", as Europe faces an increase in Covid-19 contaminations.

"The Committee will now send its recommendations on these two drugs to the European Commission, which will take legal decisions quickly," the statement said, adding that the EMA is currently evaluating six other drugs "which may receive marketing authorization in short deadlines ”.

The Commissioner in charge of Health, however, recalled that vaccination remained to this day "the only preventive solution to get out of the crisis", inviting the continuation of the vaccination campaign across the European Union.