The battle against Covid-19 proceeds rapidly. In the coming days, the European Medicines Agency (Ema), the European medicines agency, is expected to release the authorization for the use of two monoclonal antibodies for patients with Covid-19, the first approval for similar therapies. And what was reported to Reuters by two sources from the European Union. Specifically, it is a cocktail of antibodies known in the United States as Regen-Cov – while in the rest of the world it will be sold as Ronapreve – and developed by the US biotech company Regeneron Pharmaceuticals together with the Swiss giant Roche. At the moment, the only cure against Covid-19 approved by the EMA since the pandemic began is Remdesivir, an antiviral drug developed by the US Gilead Sciences.
Regeneron’s developed antibody cocktail has already obtained emergency clearance in the United States in 2020, and received conditional marketing approval in the UK in August. Demand for the antibody cocktail in the US was so strong that the manufacturer reported quarterly revenues beyond expectations last week. The drug is now being evaluated by the EMA and will undergo a lengthy process which, according to sources, will result in a full marketing authorization. Furthermore, in June, according to a spokesman for the European Commission, the blockade would have made an agreement for the supply of 55 thousand doses of the drug.
Also this week, according to an anonymous source, the European medicines agency will authorize the use of another drug based on monoclonal antibodies, Regkirona, developed by the South Korean pharmaceutical company Celltrion Healthcare. The blockade does not currently have a supply agreement with Celltrion, whose antibody-based drug has so far only been approved in South Korea. A second source familiar with the authorization process reported that both drug approvals are “imminent”, even if a precise date has not yet been established. The requests for approval, in fact, were presented at the beginning of October, when the EMA declared it “can express an opinion within two months”.
The authorizations would come at a time when Europe is facing a new threatening spike in infections and hospitalizations, despite the high levels of vaccination in several EU states. Currently, both Regen-Cov and Regkirona are in use to treat Covid-19 patients who are at risk of developing severe symptoms. In the first quarter of this year, EMA issued recommendations to national authorities on how to use both drugs before their full approval, the first step towards their use in several European countries.
So far, the EMA hasn’t commented on the status of the approvals, but said the two drugs will be reviewed during the agency’s monthly meeting of the agency’s committee in charge of treatment authorizations, which began yesterday and runs through Thursday. The evaluations also come after last week Eli Lilly, a global pharmaceutical company based in Indianapolis, revoked the authorization request in Europe for its antibody-based drug, due to the weakness of demand from member states. EU, focus on other suppliers. The marketing authorization of the two drugs will allow the use of treatments even where not yet approved by national agencies, reducing the legal risks for the governments of the countries that have already begun to distribute them.
Also on the vaccine front, the situation seems to be proceeding in positive terms. The European Union has already immunized over 75% of the adult population, although some countries report vaccination rates below 40%. Last Tuesday, moreover, the American company Moderna announced that it had requested an evaluation from the EMA on the use of its anti Covid-19 vaccine in children aged between 6 and 11 years, at the same time filing a request for the variation of the conditional authorization of the sale.
As of July, the vaccine had already been authorized for use in adolescents aged 12-17 by the European Union. However, several countries, including Sweden, have suspended its use for people aged 30 and under due to some rare cardiovascular-related side effects. In June, the drug manufacturer then applied for U.S. authorization for its vaccine for use in adolescents, and is now awaiting a decision by the U.S. Food and Drug Administration (FDA).
“This marks our first request for the use of our vaccine in this age group,” said Stephane Bancel, CEO of Moderna, adding that the company will submit the data to other regulatory agencies around the world.
