December 3, 2018 / 6:47 AM / 7 days ago

Novartis SMA treatment could get FDA approval in May

FILE PHOTO: Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo

ZURICH (Reuters) - Novartis’s (NOVN.S) gene therapy for spinal muscular atrophy (SMA) could be approved in May 2019 after the U.S. Food and Drug Administration agreed to an accelerated review of the Swiss drugmaker’s treatment.

Novartis SMA treatment, now called Zolgensma, said on Monday it won FDA priority review after submitting clinical trial results for 15 patients, all of whom are alive at 24 months. The treatment may become one of the most-expensive one-time therapies ever, with Novartis pegging its value at $4-$5 million (£3.13-3.92 million) per patient.

Reporting by John Miller

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