Novartis’s Zolgensma Loses EU Accelerated Assessment
Companies pleased at gaining an EU accelerated assessment for a product should be aware that the agency offers no guarantee that they will get to keep it. Novartis’s Zolgensma is one of seven drugs whose review the EMA has taken off the fast track.
You may also be interested in...
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.
Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU.
The Swiss major believes it responded in a timely fashion to data manipulation issues associated with its closely watched gene therapy but CEO Vas Narasimhan's bid to rebuild trust with society has taken a hit.