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Dallas – March 19, 2015 – AveXis, Inc., a biotechnology company focused on using gene therapy to transform the lives of patients with severe genetic and orphan diseases like Spinal Muscular Atrophy (SMA), today announced that the European Medicines Agency (EMA) has granted AveXis’ wholly owned European subsidiary, AveXis EU Ltd., SME (Small and Medium Sized Business Entities) status.
The EMA, recognizing the need to encourage drug development by small biotech companies, established the SME program in late 2005 which offers incentives to small and medium business for drug product development. Companies with SME status can receive administrative assistance and reduced/deferred fees associated with regulatory processes, scientific advice, and/or inspections.
AveXis has also continued its efforts to grow awareness of the ongoing and upcoming clinical trials with the Contact All Neurologists (C.A.N.) ProgramTM. The C.A.N. ProgramTM has reached neurologists nationwide, informing them of clinical trials available to infants recently diagnosed with SMA Type 1. For neurologists, pediatricians, genetic counselors or physicians interested in participating in the AveXis C.A.N. ProgramTM, please contact CAN@avexisinc.com.
To learn more about the Gene Transfer Clinical Trial, other available trials for SMA, and SMA patient advocacy group, please visit: www.smastudy.org, a patient-oriented, SMA-focused web resource.
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