Monday, August 29, 2016

Expanded Access Program for Nusinersen in Participants for SMA 1 type

In soon time we wait for a miracle drug for SMA

Biogen is working to open a global expanded access program (EAP) for eligible patients with infantile-onset SMA (consistent with Type 1) in the coming months. The EAP can be initiated at existing nusinersen clinical trial sites in countries where EAPs are permitted according to local laws and regulations, can be operationalized, and where there is a path that can support long-term availability of nusinersen. Once the EAP is operational and required local approvals are in place, individual participating sites may start enrollment after they have transitioned ENDEAR study participants to the open-label extension study.

More information on the EAP can be found on the clinicaltrials.gov website under the NCT identifier NCT02865109 https://clinicaltrials.gov/ct2/show/NCT02865109

Full text: http://www.curesma.org/news/important-milestone-reached.html

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