Regeneron Pharmaceuticals’ monoclonal antibody treatment will be tested in Romania, Mediafax reported.

U.S. president Donald Trump received the experimental antibody drug as part of his treatment for Covid-19.

The Matei Balș Institute in Bucharest filed an approval request for the clinical trials on the drug in mid-August. They received the approval from the National Drug Agency this week. 

The approval request covered three clinical trials, for several categories of patients.

 “These were treated as a priority and are currently authorized, after undergoing the compulsory evaluation procedure and proving that all current legal requirements are met for patient treatment. We mention that this is an investigational drug. Until receiving the approval for selling the product, according to current legislation, the drug needs to undergo the clinical investigation phase – the clinical studies; it is administered to human subjects to prove its efficacy and safety. The evaluation procedure of the clinical studies is compulsory to ensure the protection of the subjects of a clinical trial,” the National Drug Agency told Mediafax.

Regeneron’s REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, its manufacturer explains. In a press release at the end of September, the company said the first data from an ongoing trial showed REGN-COV2 reduced the viral load and the time to alleviate symptoms in non-hospitalized patients with Covid-19.

(Photo: Akvaphoto2012/ Dreamstime)

simona@romania-insider.com