US FDA approves Novartis' gene therapy for rare muscle disorder

By Sriparna Roy and Bhanvi Satija

(Reuters) -The U.S. Food and Drug Administration has approved Novartis’ gene therapy for patients with a rare muscle disorder, the drugmaker said on Monday.

The therapy, branded as Itvisma, was approved for the treatment of spinal muscular atrophy patients of age two years and older who have a confirmed mutation in the survival motor neuron 1 gene.

Itvisma contains the same active ingredient as the Swiss drugmaker’s older therapy, Zolgensma, which is approved in the U.S. to treat SMA patients less than 2 years of age.

The new treatment has a wholesale acquisition cost of $2.59 million, compared with $2.1 million for Zolgensma.

Itvisma is the first and only gene replacement therapy available for the broad population, Novartis said.

“(This) gives patie