EMA Starts Rolling Review of Regeneron’s Antibody Cocktail for COVID-19

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has begun a rolling review of Regeneron’s REGN-COV2 antibody combination (casirivimab/imdevimab) for treating and preventing COVID-19.

The committee said it decided to kick off its review based on preliminary trial data that showed the cocktail helped to reduce the amount of viral load in non-hospitalized COVID-19 patients, but cautioned that it has not yet fully evaluated the study and cannot yet make a risk-benefit evaluation.

The monoclonal antibody cocktail received the FDA’s Emergency Use Authorization (EUA) in November for treating patients with mild-to-moderate COVID-19 symptoms at high risk of progressing to severe disease or hospitalization (DID, Nov. 24, 2020).

Regeneron recently disclosed that it has seen promising phase 3 interim results suggesting the treatment could serve as a passive vaccine. The drugmaker said it will discuss the findings with regulators and seek an expanded EUA from the FDA based on the data. The full results from the National Institutes of Health (NIH)-supported trial evaluating the antibody cocktail as a passive vaccine are expected in the second quarter (DID, Jan. 27).

At its Jan. 29 monthly meeting, the committee also recommended AstraZeneca’s COVID-19 vaccine for conditional marketing authorization for patients 18 and up. The vaccine went on to receive the authorization from the EU hours after the CHMP’s recommendation (DID, Feb. 1).

The committee in total recommended 13 drugs for approval. These included Novartis’ Kesimpta (ofatumumab) for treating adults with active relapsing forms of multiple sclerosis, Acacia Pharma’s Byfavo (remimazolam) for procedural sedation, and Amarin Pharmaceuticals’ Vazkepa (icosapent ethyl) for reducing the risk of cardiovascular events in patients at high cardiovascular risk, among others.

The CHMP also gave positive opinions for two Avastin (bevacizumab) biosimilars, mAbxience Research’s Alymsys and STADA Arzneimittel’s Oyavas, for treating carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. It also gave a positive opinion for Riemser Pharma’s generic Thiotepa Riemser (thiotepa) for use as a conditioning treatment prior to hematopoietic progenitor cell transplantation. — James Miessler