Breakthrough Therapy Designation for MS Drug
The US Food and Drug Administration has granted breakthrough therapy designation for ocrelizumab (Ocrevust/Roche).
The US Food and Drug Administration has granted breakthrough therapy designation for ocrelizumab (Ocrevust/Roche) the Basel, Switzerland manufacturer announced Feb. 17.
The drug is meant to treat primary progressive multiple sclerosis (PPMS), a condidtion for which there are currently no approved treatments.
Roche said it plans to pursue authorization to market the drug both for PPMS and relapsing MS, the more common form of the disease.
It expects to submit Phase III study data to the FDA within a few months. The study is called ORATORIO. Topline results were presented at the European Committee for Treatment and Research in Multiple Sclerosis in October.
The drug is a humanized monoclonal antibody designed to selectively target CD20-positive B cells.
These immune cells are thought to play a key role in maintain mylelin, the nerves' insulator.
Based on preclinical studies, the drug appears to bind to CD20 cell surface proteins and protect them from deteriorating..
