dm+d

Unassigned

New Medicines

RegkironaCoronavirus disease 2019 (COVID-19) - treatment and post-exposure prophylaxis

Information

Regkirona
New molecular entity
Celltrion
Celltrion

Development and Regulatory status

None
Pre-registration (Filed)
None
Jun 21The EMA has identified five "most promising" COVID-19 therapeutics already in an advanced stage of development that it will prioritise, with the aim of providing more regulatory flexibility with rolling reviews, conditional marketing authorisations and flexible labelling and packaging requirements. At least three of these new products will be authorised by Oct 2021. Regdanvimab is one of the 5 products [9].
Mar 21EU CHMP has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59). It recommends regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on reasonable likelihood that the medicine may provide clinical benefit and a low likelihood of harm [7].
Feb 21EMA start rolling review of regdanvimab for COVID-19 [6].
Dec 20Celltrion plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to the European Medicines Agency (EMA) for CT-P59 in the coming months [4].
Nov 20PII trial recruitment complete, global PIII trial planned [1].

Category

Potent monoclonal antibody against SARS-COV-2 virus including the mutated G-variant strain D614G
COVID-19 is an infectious disease caused by coronavirus SARS-CoV-2. Most people infected experience mild to moderate respiratory illness and recover without requiring special treatment. Older people and those with underlying medical problems are more likely to develop serious illness [2].
Coronavirus disease 2019 (COVID-19) - treatment and post-exposure prophylaxis
Intramuscular

Trial or other data

Jun 21PIII study (n=1,315) shows regdanvimib reduces risk of hospitalisation/death by 72% for patients at high-risk of progressing to severe COVID-19 to day 28 [3.1 vs 11.1 %; p< 0.0001] and reduced risk of hospitalisation/death by 70% in all patients [2.4 vs 8.0 %, p < 0.0001] vs placebo [8].
Jan 21Celltrion announced that in a trial of CT-P59 the 40mg/kg dose reduced progression to severe COVID-19 by 54% versus placebo at day 28. In a subgroup of moderate COVID-19 patients aged 50 years and over, the reduction was 68%. More than half of the moderate COVID-19 patients in the study had pneumonia related to the virus. Patients on the low dose of CT-P59 recovered in 5.4 days, as compared to 8.8 days in the placebo arm. The difference in recovery times was larger in certain subgroups of patients. Subjects suffering from pneumonia recovered in 5.7 days on the low dose of CT-P59, versus 10.8 days for their peers on placebo. In patients aged 50 years and older, the CT-P59 and placebo recovery times were 6.6 days and 13 days, respectively. Viral load fell significantly versus placebo at Day 7[5].
Nov 20PII/III Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection, primary completion due Dec 20 [3].