Intrathecal Zolgensma Delay Could Allow Competitors To Shine
US FDA Requests Confirmatory Clinical Study
The rollercoaster ride continues for Novartis’s gene therapy Zolgensma, with the company committing to providing further clinical data on an intrathecal formulation for older spinal muscular atrophy patients.
You may also be interested in...
With $1.1bn in cash plus revenue from its existing commercial products and royalties from Roche’s sales of newly approved Evrysdi to invest in R&D, PTC Therapeutics may achieve profitability in 2023.
Biogen said some spinal muscular atrophy patients are currently being treated with Spinraza after receiving the Novartis gene therapy – its main competitor – so it will start a study of the risk/benefit in 2021.
The Swiss major is offering a ‘Day One’ access program to governments and reimbursement agencies for Zolgensma, which is already available in France and will be shortly in Germany.