Therapy Areas: Central Nervous System
US Food and Drug Administration grants Breakthrough Therapy Designation to Viela Bio's inebilizumab
23 April 2019 -

The United States Food and Drug Administration (FDA) has granted approval to United States-based Viela Bio for its Breakthrough Therapy Designation of anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, life-threatening disease of the central nervous system, it was reported yesterday.

Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of medicines aimed to treat a serious condition that have indicated encouraging early clinical results that may showcase substantial improvement on a clinically significant endpoint over available medicines.

The designation for the product is based on data from the pivotal N-MOmentum study assessing inebilizumab as monotherapy. The study enrolled 231 NMOSD patients for 6.5 months. The primary endpoint was time from initiation of treatment to an NMOSD attack.

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