The antibody cocktail treatment against the coronavirus, which was given to then-president Donald Trump last year, has been authorised for use in Belgium.
The treatment known as REGN-COV2, which works by using two antibodies made to act like human antibodies in the immune system and attack the spike protein of the virus, has been approved by the government, the Federal Agency for Medicines and Health Products (FAMHP) has announced.
“Interim results showed that the REGN-COV2 antibody cocktail significantly reduces viral load in patients with SARS-CoV-2 virus and reduces Covid-19-related medical contacts,” the agency said in a statement released on Thursday.
The ministerial decree, issued by Federal Health Minister Frank Vandenbroucke on Wednesday, stated that the treatment can only be prescribed by “a doctor associated with a hospital after a prior favourable opinion by a multidisciplinary panel of health experts, which should include an infectious disease expert and an immunologist.”
People who have received the treatment developed by the US laboratory Regeneron should also be followed up by the hospitals that carried out the treatment, the decree emphasised.
The medicine has not yet been licensed but did receive a positive scientific opinion from the European Medicines Agency (EMA) in February this year in a review aimed at helping support national decision-making on the possible use of the antibodies prior to marketing authorisation.
EMA added that the treatment could help patients who do not yet require supplementary oxygen but are at high risk of developing a severe infection by reducing the viral load (amount of virus in the back of the nose and throat) more than placebo (a dummy treatment) and led to fewer Covid-19-related medical visits.
When Trump contracted coronavirus last year, he received the cocktail even before it was authorised by the US Federal Drug Agency (FDA) in late November. The then-president has said the treatment had “cured” him.
Before EMA released its opinion on the treatment, Germany became the first European Union country to use the experimental, antibody cocktail in January this year, when the government bought 200,000 doses for €400 million.