Regeneron headquarters in Tarrytown, New York: Can the drug reduce the amount of viruses in the blood?
Photo: Lev Radin / Pacific Press Agency / imago images
The European Medicines Agency (Ema) has started testing a corona drug from the pharmaceutical company Roche and its partner Regeneron.
The Ema Committee for Medicinal Products for Human Use is investigating REGN-COV2, which is based on the combination of two antibodies, according to a statement from the authority on Monday evening.
The drug, which was jointly developed by the US manufacturer Regeneron and Roche, is said to have been used last year to treat the Covid-19 infection of the then US President Donald Trump.
According to Ema, the effectiveness test is carried out as part of a so-called rolling review process.
Experts evaluate data from studies, even if these tests have not yet been completed and no application for approval has yet been submitted.
The approval process can be shortened in this way.
According to Ema, a study suggests that the agent can reduce the amount of viruses present in the blood.
But it is still too early to draw conclusions about the relationship between benefits and risks.
In the USA, REGN-COV2 has an emergency approval from the FDA.
It is still open whether the Ema will recommend approval to the EU Commission.
The Regeneron agent is currently being tested in a phase II / III study with outpatients.
According to the Association of Research-Based Drug Manufacturers (vfa), REGN-COV2 also shows antiviral effects in hospitalized Covid-19 patients.
In addition, a phase III study is running in parallel, in which volunteers are given it for prevention.
Antibody drugs ordered for Germany
Health Minister Jens Spahn (CDU) announced the purchase of 200,000 doses of two antibody drugs for corona treatment for around 400 million euros at the end of January.
They are to be used initially in university clinics for high-risk patients in the early phase.
In addition to REGN-COV2, the ministry ordered a product from the US pharmaceutical company Eli Lilly, which also contains so-called monoclonal antibodies.
In therapy with antibodies, patients suffering from Covid-19 receive a cocktail of artificially generated corona antibodies that have been cloned in the laboratory, i.e. duplicated identically.
Monoclonal means that the antibodies used are all the same and attack the virus at a clearly defined target.
They are directed against a key protein of the Sars-CoV-2 virus, i.e. they dock on the coronavirus and thus prevent it from entering the cells.
The virus can only multiply there.
In the case of the Regeneron preparation, the active ingredient dose contains two different monoclonal antibody variants in order to also include a possible mutation of the virus.
Research is also being carried out into combinations with three antibodies.
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kry / dpa