ZURICH, May 8 (Reuters) - Novartis is confident it has adequate production capacity for its Zolsgensma gene therapy should regulators this month approve the drug for multiple forms of the genetic disease spinal muscular atrophy, the Swiss drugmaker said on Wednesday.
“Ultimately, they (the U.S. Food and Drug Administration) will have to weigh in on exactly where we land on the label,” Novartis’s David Lennon, who heads the Zolgensma program, told analysts on a call. “We remain very confident around our ability to supply the market under a range of scenarios for what the FDA might grant us in terms of approval.”
Lennon also said a media report this week suggesting Zolgensma would be priced at $2 million per patient was “complete speculation.” Novartis has said it is considering a range between $1.5 million and $5 million.
Reporting by John Miller; editing by Brenna Hughes Neghaiwi