EMA: Ongoing study data of Celltrion’s mAb enough to allow its use in some Covid-19 patients
The European Medicines Agency added another monoclonal antibody to the continent’s Covid-19 therapeutics arsenal on Friday, concluding that Celltrion’s regdanvimab can be used as a treatment for adults with Covid-19 who do not require supplemental oxygen and who are at high risk of progressing to severe Covid-19.
The EMA said its recommendation is based on a review of data from the first part of an ongoing study showing regdanvimab may lower the rate of hospitalizations in adult outpatients with Covid-19 symptoms described as mild to moderate who do not need supplemental oxygen.
“However, the results were not robust enough to reach a firm conclusion on the medicine’s benefits at this point in time,” EMA said. “In terms of safety, most side effects reported were mild or moderate. Reactions related to the infusion (including allergic reactions) cannot be excluded and healthcare professionals should monitor patients for these reactions.”
Despite the uncertainties, EMA concluded that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe Covid-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.
Celltrion said in February that its mAb, also known as CT-P59, reduced the rate of progression to severe Covid-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over.
A global Phase III clinical trial is still recruiting and is expected to enroll 1,172 patients with mild-to-moderate symptoms of Covid-19 at more than 10 global sites to evaluate the efficacy and safety of the treatment.
While the antibody treatment is currently not authorized in the EU, the EMA’s recommendation on Friday provides a harmonized scientific opinion at the EU level to support national decision making on the possible use of it. A rolling review by the EMA for regdanvimab, which started in late February, is ongoing and will be the basis for a marketing approval, the agency said. The US FDA has yet to authorize the Celltrion monoclonal antibody.
Celltrion also said the Korea Disease Control and Prevention Agency has assessed and independently confirmed that the mAb successfully neutralizes the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of the novel coronavirus. They also said that a cocktail therapy of CT-P59 with another mAb candidate demonstrated neutralizing capabilities against the variants originating in the UK and South Africa (B.1.351).