Covid-19: EU drug watchdog approves two new antibody treatments

The EU’s drug watchdog on Thursday approved two Covid-19 antibody treatments, in its first approvals of the groundbreaking therapies that help stop infected people developing symptoms of the disease.

Ronapreve, made by Swiss pharma giant Roche with US biotech firm Regeneron, and Regkirona, developed by South Korea’s Celltrion, got the green light from the European Medicines Agency (EMA).

The move adds to the European Union’s toolbox of drugs as it fights coronavirus infection rates that are rising to record levels in some countries.

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“Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion... for Covid-19,” the Amsterdam-based EMA said in a statement.

EU Health Commissioner Stella Kyriakides said the approval of the two drugs was an “important step” against the disease, with the bloc’s response so far relying on four vaccines.

“With Covid-19 infections on the rise in almost all member states, it is reassuring to see many promising treatments in development as part of our COVID-19 therapeutics strategy,” she said in a statement.

“Today we take an important step forward towards our goal of authorising up to five new treatments in the EU by the end of the year.”

EU states could already call on the bloc’s contract for 55,000 treatments of Ronapreve, she said.

Lab-produced monoclonal antibodies are Y-shaped proteins that bind to the spikes that dot the surface of the coronavirus, stopping the pathogen from invading human cells.

Vaccines train immune systems to produce such antibodies too.

But some people including the elderly and immunocompromised do not respond well to vaccines, and such groups stand to benefit the most from “passive vaccination” where the antibodies are delivered directly.

• Europe