On Thursday 16 December, the European Medicines Agency (EMA) recommended the use of two new treatments for Covid-19: - Xevudy (sotrovimab), the monoclonal antibody developed by GSK (see EUROPE 12835/21); - Kineret (anakinra), an immunosuppressive drug previously authorised in the EU for the treatment of inflammatory conditions.
The EMA says that Xevudy is intended for the treatment of Covid-19 in adults and adolescents aged 12 years and over who are at increased risk of developing a severe form of the disease, but do not require supplemental oxygen.
As for Kineret, the European Agency recommends that its authorisation be extended to the treatment of Covid-19 in adults with pneumonia, requiring supplemental oxygenation and at risk of developing severe respiratory failure.
In addition, on Thursday, the EMA issued an opinion on the emergency use of the oral treatment Paxlovid (PF-07321332/ritonavir), as it did a month ago for Merck’s candidate treatment (see EUROPE 12836/20).
This opinion is intended to support national authorities who may wish to opt for emergency use of the medicinal product pending marketing authorisation.
The candidate treatment can be used in adults with Covid-19 who do not require supplemental oxygen but are at increased risk of progression to severe disease, according to the EMA.
Booster doses and manufacturing sites
On Wednesday, the agency also concluded that a booster dose of Johnson & Johnson’s Covid-19 vaccine could be considered at least 2 months after the first dose in people aged 18 and over.
From now on, this vaccine will also be produced in France, as a new manufacturing site for the finished product has been approved by the EMA in Marcy-l'Étoile.
Finally, the EMA gave positive opinions for an increase in the production of Moderna’s vaccine (Spikevax) at the Madrid site and for an increase in the production of the active substance of Pfizer/BioNTech’s vaccine Comirnaty at the US site in Andover. (Original version in French by Agathe Cherki)