The world's most expensive drug has been approved by the FDA and will hit the market with a $2 million price tag
Novartis’s one-time treatment for a devastating infant muscle-wasting disease won approval from the FDA Friday. Photo: /Associated Press By Denise Roland Updated May 24, 2019 6:59 p.m. ET The world’s most expensive medicine is about to hit the market.
Gene therapies promise the chance to cure diseases whose diagnoses were death sentences, but the prices for the first few to be greenlighted raise concerns about whether they can be afforded by governments and health insurers that have been struggling to control health spending. Novartis also defended the overall price by comparing it to a treatment already on the market. David Lennon, head of Novartis’s AveXis unit that developed Zolgensma, said in a call with reporters it would cost half that of the current standard treatment, Spinraza, over a 10-year period.
ICER had previously said Zolgensma should cost no more than $1.5 million, but updated its analysis after new clinical trial data showed promising results in very young babies treated before the symptoms of SMA set in.Zolgensma “is highly cost effective and represents a product at a fair and reasonable price,” Dr. Lennon said.
“Today’s approval marks another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases,” acting FDA Commissioner Ned Sharpless said in a statement. Novartis had been trying to lay the groundwork for Zolgensma’s price tag by talking publicly about a multimillion-dollar figure and playing up the therapy’s effectiveness.
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