The European medicines Agency (Ema) has started the examination of the Corona-drug of the pharmaceutical company Roche and its Partner Regeneron. The Ema-Committee for medicinal products for human use under the search on the combination of two antibodies based medium-REGN-COV2, it said in a communication to the authority from Monday evening.
The drug, which was jointly developed by the US manufacturer, Regeneron, and Roche, is said to have been used in the past year for the treatment of Covid-19 infection of the then US President, Donald Trump.
According to the Ema, the effectiveness test is carried out in the framework of a so-called Rolling Review process. Here, experts evaluate data from studies, even if these Experiments are not yet completed and still no application for authorisation has been made. The approval procedure can be shortened in this way.
The Ema, according to a study indicates that the agent can reduce the in the blood amount of virus. However, it is still too early to draw conclusions about the relationship between the Benefits and the risks. In the United States for REGN-COV2 an emergency approval, the drug administration FDA. Whether the Ema, the EU will recommend to Commission the approval, is still open.
Currently, the Regeneron-means is being tested in a Phase II/III study of outpatient-treated patients. Also in hospitalized Covid-19-patients REGN-COV2 show according to the Association of research-based pharmaceutical manufacturers (vfa) anti-viral effects. In addition, a Phase III study, in which it is Voluntary for the prevention of the course in parallel.
Antibody drugs for Germany
The Minister of health, Jens Spahn (CDU) had announced at the end of January for the purchase of 200,000 doses of the two anti-body drugs for the Corona treatment for approximately 400 million Euro. You should be in University hospitals in at-risk patients in the early phase used. In addition to REGN-COV2 the Ministry ordered a medium in the US pharmaceutical company Eli Lilly, the so-called monoclonal antibody contains.
In the case of the therapy with antibodies the to get Covid-19 diseased patients a Cocktail of artificially-generated Corona-immune substances, which are cloned in the lab, so identical were reproduced. Monoclonal means that the antibodies are not all the same and the Virus to a defined target to attack. They are directed against a key protein of the Sars-CoV-2 Virus, dock so to the Coronavirus and prevent so that it penetrates into the cells. Only there you can reproduce the Virus namely.
The dose of active Substance contains, in the case of Regeneron preparation of two different monoclonal antibody variants, even a possible Mutation of the Virus to include. The research materials already on combinations with three defenses.
