Longmont-made Zolgensma lands sale approval in Japan

TOKYO and LONGMONT — Drug regulators in Japan have approved Zolgensma, the drug due to be produced in AveXis Inc.’s recently-opened Longmont plant, for use in treating infant spinal muscular atrophy (SMA) in the country

The announcement, made by AveXis’s parent company Novartis AG (NYSE: NVS) Thursday morning, marks the second country to green-light the drug for sale behind the U.S., which approved it last spring.

Japan does not test newborns for SMA, but an August 2018 research in the medical publication Brain and Development estimates 2.7 children out of every 100,000 live births in the country have the genetic disorder.

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Zolgensma is a one-time infusion to treat SMA, which inhibits the ability in infants to develop strength in their spines and kills the majority of patients before they reach the age of 2.

The drug is also one of the most controversial on the market for its price of $2.1 million, making it the most expensive drug in the world for a single dose. AveXis was also heavily criticized by the U.S. Food and Drug Administration when it discovered pre-human trial data manipulation and from patient access advocates when it said it would give away 100 doses in a lottery between 2019 and 2020 in countries that have yet to approve the drug for sale.

AveXis purchased and retrofitted a 692,000-square-foot plant in Longmont formerly owned by AstraZeneca PLC (NYSE: AZN) before the company abandoned it and a Boulder facility last March. The company also recently opened a sister manufacturing plant in Raleigh, North Carolina.

That location, which is awaiting approval from the U.S. Food and Drug Administration to begin producing Zolgensma en masse later in the year or early 2021, can produce between 800 to 1,200 doses annually and employ up to around 400 people once at maximum capacity.