AstraZeneca’s NMOSD Drug receives orphan drug designation

European Medicine Agency has Announced orphan drug designation for inebilizumab (earlier known as MEDI-551) developed by AstraZeneca PLC (AZN) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).  The drug has already received orphan drug status from US Food and Drug Administration (FDA). NMOSD, also called Devic’s disease, is a rare, autoimmune disorder of the central nervous system (CNS) that affects the functioning of optic nerves and spinal cord. It leads to blindness, bladder and bowel problems, loss of sensation, severe muscle weakness, paralysis, and other related symptoms. Autoimmune diseases are the ones in which the body’s immune system attacks healthy cells.

EMA orphan designation is intended to encourage development of medicines for the diagnosis, treatment, or prevention of life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU. Medicines that receive orphan designation are eligible for a number of incentives, including assistance with development of the medicine; reduced fees for marketing-authorization applications; and extended market exclusivity once the medicine is authorized. Orphan designation is conferred following a positive opinion by the EMA’s Committee for Orphan Medicinal Products (COMP).

“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.

 

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