The European Commission recently approved Zolgensma, Novartis' $2.1 million gene therapy drug for spinal muscular atrophy, for infants and children up to 46 pounds.
Zolgensma was developed by AveXis, a biotechnology company acquired by Novartis for $8.7 billion in 2018.
AveXis is negotiating with governments and reimbursement agencies to decide on terms of the "Day One" access program, which would provide rapid access in all countries in the European Union.
In May 2019, the FDA approved Zolgensma for infants under the age of 2, with the drug totalling $361 million in sales last year.
Zolgensma recently gained approval in Japan. Novartis expects decisions to be made by Swiss, Canadian and Australian authorities in late 2020 or early 2021.