Celltrion Healthcare announces acceptance and priority review by Health Canada of New Drug Submission for its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59)

Celltrion Healthcare Canada Limited announced today that the New Drug Submission (NDS) file for regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19, submitted to Health Canada as rolling submission on May 28, 2021 has completed the screening phase. Regdanvimab (CT-P59) has been screened and found acceptable for review as a New Drug Submission with flexibilities for designated COVID-19 drugs (NDS-CV).

The rolling submission process was recommended and accepted under the Minister of Health’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD IO) and transitioned to a New Drug Submission for COVID-19, which permits companies to submit safety and efficacy data and information as they become available. Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.

The Food and Drug Regulations have been amended to allow for modified requirements that facilitate the regulatory process for new COVID-19 drugs to receive a notice of compliance (NOC) through a new drug submission (NDS). The amendments maintain some of the mechanisms introduced through the ISAD IO, thus continuing to provide Canadians with quick access to safe and effective COVID-19 drugs.

“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,” said Jovan Antunovic, Commercial Director at Celltrion Healthcare Canada. “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.”

Celltrion’s global Phase III data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalization, oxygen therapy or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients compared to placebo. In addition, patients who were treated with regdanvimab (CT-P59) reported a significantly shortened time to clinical recovery by at least 4.7 days for patients at high- risk of progressing to severe COVID-19 and by 4.9 days compared to placebo for all patients.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has made its recommendation for regdanvimab (CT-P59) that CT-P59 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.