Canadian biopharmaceutical company, Celltrion Healthcare Canada Ltd., has been granted priority review by Health Canada for its new COVID-19 treatment, Regdanvimab ̶ a monoclonal antibody.
The company, in May, had filed a new drug submission (NDS) to the agency. The screening phase of the drug has been completed and application has been approved for rolling review, according to the company.
The rolling submission has allowed the company to submit safety and efficacy data in a continuous manner as soon as it becomes available, accelerating the overall reviewing process by the agency.
Jovan Antunovic, Celltrion Healthcare Canada commercial director, stated, “We are pleased the new drug submission has been screened and accepted for review by Health Canada and anticipate this accelerated review process will enable people in Canada to have access to safe and effective treatment against Covid-19 as early as possible.”
He further added, “The initiation of a rolling submission for Regdanvimab (CT-P59) in Canada is a significant milestone and we remain committed to closely working with the Canadian regulatory authorities.”
The data obtained from the pre-clinical trials has indicated that the antibody has the potential to neutralize the SARS-CoV-2 virus by attaching to its receptor-binding domain (RBD).
Global phase III trials of the drug have mitigated the risks of hospitalization, oxygen treatment and death due to COVID-19, by 72%, in patients having high vulnerability to the disease.
On the whole, for all treated patients, 70% risk has been reduced through the drug in contrast to the placebo.
Besides, the drug has offered a minimum of 4.7 days decrease in clinical recovery time in patients with higher risks of disease progression; and for overall patient population, it has offered a 4.9 days decrease, comparing with placebo.
By March, Regdanvimab managed to get recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), to be used as a treatment for patients with high progression risks of COVID-19.
Currently, Celltrion is working on developing an antibody cocktail with Regdanvimab, to neutralize several emergent variants of SARS-CoV-2.
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