Novartis to launch new Zolgensma trial after FDA lifts restriction

ZURICH, Aug 3 (Reuters) – Novartis (NOVN.S) will launch a new phase three study to expand the use of Zolgensma – the world’s most expensive one time therapy at $2.1 million per patient treatment – after the U.S. regulator lifted its restrictions.

The Swiss company will study the use of the drug for patients aged between 2 and 18 for the treatment of spinal muscular atrophy, it said on Tuesday.

The decision comes after U.S. Food and Drugs Administration said existing trials may proceed, thereby lifting the partial clinical trial hold imposed in October 2019, after Novartis supplied new data.

FILE PHOTO: The logo of Swiss drugmaker Novartis is pictured at the French company’s headquarters in Rueil-Malmaison near Paris, France, April 22, 2020. REUTERS/Charles Platiau/File Photo

Novartis said it March it was laying off 400 people and closing a U.S. gene therapy location as sales momentum for Zolgensma stalled last year.

Zolgensma’s sales have been hurt, in part, by blocked efforts to expand its use in older patients after safety concerns prompted Novartis to pause a trial in order to collect more data for the U.S. Food and Drug Administration.

Reporting by John Revill Editing by Caroline Copley

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Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-launch-new-zolgensma-trial-after-fda-lifts-restriction-2021-08-03