Benzinga | May 5, 2021 09:27AM EDT

India Gives Emergency Use Nod To Roche-Regeneron's COVID-19 Antibody Cocktail

* Roche Holdings AG (OTC:RHHBY) has received Emergency Use Authorization in India for its investigational antibody cocktail (casirivimab and imdevimab) for treatment of COVID-19.

* Cipla will partner for pan-India distribution. Roche and its partner Regeneron Pharmaceuticals Inc (NASDAQ: REGN) are collaborating at a global level.

* The approval was based on the data filed for the EUA in the U.S. and the scientific opinion of the Committee for Medicinal Products for Human Use in the European Union.

* Emergency Use Authorization will enable Roche to import the globally manufactured product batches to India and market as well as distributed in India through a strategic partnership with Cipla Limited.

* In March, Roche announced that a large phase 3 global trial in high-risk non-hospitalized COVID-19 patients met its primary endpoint, showing that Casirivimab and imdevimab significantly reduced the risk of hospitalization or death by 70% compared to placebo.

* Casirivimab and imdevimab also significantly shortened the duration of symptoms by four days.

* Price Action: RHHBY shares closed at $40.73, and REGN closed at 485.18 on Tuesday.