EMA grants orphan drug designation to AB-201 for juvenile batten disease

Release Date: 10-Jan-2017

Abeona Therapeutics, a biopharmaceutical company announced that European Medicines Agency (EMA) has granted orphan drug designation to the company’s novel candidate AB-201 to treat patients with Juvenile Batten Disease, a fatal lysosomal storage disease of the nervous system caused by autosomal-recessive mutations in the CLN3 gene.

The EMA’s designation of orphan status is granted to encourage new developments and therapies for rare diseases and disorders. Orphan status can be granted to those diseases that are rare. These incentives include protocol assistance, i.e. scientific advice specific for designated orphan medicines, and 10 years of market exclusivity once the medicine is on the market.

For Orphan Drug Clinical Insight Reports Contact:  neeraj@kuickresearch.com