Novartis's Zolgensma Gets Conditional EU Approval
May 19 2020 - 2:19AM
Dow Jones News
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 olivia.bugault@wsj.com
(END) Dow Jones Newswires
May 19, 2020 02:04 ET (06:04 GMT)
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