Novartis's Zolgensma Gets Conditional EU Approval

   By Olivia Bugault 
 

Novartis AG said Tuesday that its Zolgensma gene therapy for patients with spinal muscular atrophy has been conditionally approved in Europe.

The European Commission granted the approval for the treatment to Novartis's subsidiary AveXis, while also specifying the conditions under which it can be used in the E.U.

Zolgensma has been approved for use in patients with certain types of spinal muscular atrophy, the pharmaceutical giant said. "The approval covers babies and young children with SMA up to 21kg according to the approved dosing guidance," it added.

Following the approval, AveXis is now in talks with E.U. member states and reimbursements agencies to agree on final pricing terms that are decided at local level and enable a quick access to the gene therapy.

AveXis has launched a program called "Day One" that proposes different options of access and reimbursement to ministries of health and reimbursement bodies, it said.

Spinal muscular atrophy is a genetic neuromuscular disease that results in the irreversible loss of motor neurons.

Write to Olivia Bugault at [e-mail]

(END) Dow Jones Newswires

May 19, 2020 02:04 ET (06:04 GMT)

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