Health Canada has given priority review to Legdambimab (CT-P59), an experimental monoclonal antibody from Sertorion Healthcare, for the treatment of Covid-19.
In May of this year, Celltrion submitted a new drug submission (NDS) to the agency. The company said the screening phase was completed and the application was accepted for review.
The rolling submission process helps companies submit their safety as well as their validity data and information when they become available.
In addition, the ongoing availability of data allows Health Canada to begin the review process immediately and expedite the entire review process.
Jovan Antunovic, Commercial Director of Celltrion Healthcare Canada, said: As soon as possible.
“The start of rolling submissions for Legdumbimab (CT-P59) in Canada is an important milestone and we continue to promise to work closely with Canadian regulators.”
Preclinical data show that the antibody attaches to the SARS-CoV-2 receptor-binding domain (RBD) and is capable of substantially neutralizing wild-type virus.
In an international phase III trial, legdumbimab reduced the risk of Covid-19-related hospitalization, oxygen therapy, or death by 72% in patients at high risk of disease progression.
The drug reduced the risk for all treated participants by 70% compared to placebo.
In addition, legdumbimab treatment reduced the time to clinical recovery by at least 4.7 days and 4.9 days, respectively, in patients at high risk of disease progression and in the entire patient population compared to placebo.
March, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA) Recommended that regdanvimab can be used to treat patients People at high risk of developing severe Covid-19.
Celltrion is currently developing a neutralizing antibody cocktail containing legdumbimab for several SARS-CoV-2 emergency variants.