Novartis to Seek FDA Emergency Use Approval for New COVID-19 Therapy

Swiss drugmaker Novartis' logo is seen at the company's plant, in the northern Swiss town of Stein, Switzerland, on Oct. 23, 2017. Arnd Wiegmann/Reuters

Novartis said on Jan. 10 that positive data from a clinical trial of COVID-19 therapeutic drug ensovibep has prompted the firm to exercise an option to in-licence the antiviral from development partner Molecular Partners and later seek emergency use approval from U.S. regulators.

In a statement, Novartis confirmed plans to pay around $163 million to Molecular Partners to in-licence ensovibep, ramp up manufacturing more quickly, and seek faster regulatory authorizations across the globe, starting with an application for emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).