Novartis to seek FDA approval for COVID-19 treatment after positive data

Novartis to seek FDA approval for COVID-19 treatment after positive data

Novartis AG and Molecular Partners AG on Monday reported positive topline data from their antiviral Covid-19 treatment ensovibep, and will seek expedited regulatory authorizations globally.

The results from a Phase 2 study of 407 patients receiving a single intravenous dose of ensovibep showed a 78% reduction in hospitalization or emergency-room visits related to Covid-19 compared with a placebo, and a improvement in time to a clinical recovery, Novartis said.

The ensovibep treatment continues to maintain protection against variants of concern identified so far, including Omicron, the Basel-based drugmaker said.

Novartis NVS, +1.16% NOVN, +0.78% also said it will exercise its option and pay 150 million Swiss francs ($163.3 million) to in-license ensovibep from Molecular Partners MOLN, -3.39% MOLN, +29.87% and accelerate manufacturing scale-up.

It also plans to seek expedited regulatory authorizations globally, first via the U.S. Food and Drug Administration’s emergency-use authorization.



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