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news.AVI BioPharma (AVI) has received an orphan drug designation from the Committee for Orphan Medical Products of the European Medicines Agency (EMEA), for AVI-5038, a drug candidate being developed by AVI for the treatment of duchenne muscular dystrophy (DMD).
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The orphan drug designation potentially may provide AVI up to ten years of market exclusivity, if the drug candidate is approved for marketing in the EU. AVI-4658, another drug being developed by AVI for DMD, received European orphan drug designation in 2008, and also potentially may receive up to ten years of marketing exclusivity if approved in the EU.
Leslie Hudson, president and CEO of AVI BioPharma, said: “The EMEA’s granting of orphan drug designation to AVI-5038 provides important regulatory support for our continuing commitment to develop disease modifying drugs for DMD patients. We look forward to the opportunity to report continuing progress in our DMD program throughout the year, particularly with respect to our lead DMD drug candidate, AVI-4658, which is in an ongoing Phase 1b/2 clinical trial.”