EMA COVID-19 treatment evaluations update

The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).


CHMP begins rolling review of regdanvimab antibody for COVID-19

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has initiated a rolling review of Celltrion’s monoclonal antibody regdanvimab (CT-P59), which is being developed for the treatment of COVID-19.

According to the agency, this decision was taken based on preliminary results from an ongoing study evaluating the ability of the antibody to treat COVID-19. However, said it was too early to draw any conclusions regarding the benefit-risk balance of the medicine.

Under the review process, the committee has started assessing the first batch of data from preclinical animal studies and early Phase clinical trials, in addition to data on the quality of the medicine. It will continue to evaluate more data as it becomes available until there is enough evidence to support a formal marketing authorisation application.

During the review, the EMA will also assess the medicine’s compliance with the usual standards for effectiveness, safety and quality, which should expedite the decision on any future marketing authorisation application.

Regdanvimab is a monoclonal antibody which attaches to Spike (S) protein of SARS-CoV-2 (the virus that causes COVID-19) and prevents the virus from entering human cells and causing infection. This effect expected to reduce the need for hospitalisation in patients with mild to moderate COVID-19.

Committee to assess use of Veklury in COVID-19 patients not requiring supplemental oxygen

The CHMP has begun evaluating Gilead Sciences’ application to extend the use of Veklury (remdesivir) to include treating adults with COVID-19 who do not require supplemental oxygen. 

Veklury is currently authorised for use in adults and adolescents (aged 12 years and over, and weighing at least 40 kilograms) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). 

The committee will assess the submitted data and recommend whether or not the extension of indication should be authorised. This opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

A decision from the CHMP is expected before summer 2021.

Veklury was first authorised in the EU in July 2020. Its active substance, remdesivir, is a viral RNA polymerase inhibitor which interferes with the production of the viruses genetic material (RNA), thereby preventing SARS-CoV-2 virus from replicating inside human cells.