Genentech, a leading biotechnology company headquartered in San Francisco, announced that the U.S. FDA has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUS) for the treatment of people with primary progressive multiple sclerosis (PPMS). There are currently no approved treatments for PPMS, a debilitating form of MS characterized by steadily worsening symptoms and typically without distinct relapses or periods of remission. Multiple sclerosis (MS) is a chronic disease that affects an estimated 2.3 million people around the world, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. Damage to these nerves can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to progressive disability. PPMS is a debilitating form of MS characterized by steadily worsening symptoms but typically without distinct relapses or periods of remission.
Genentech plans to pursue marketing authorization for both PPMS and relapsing multiple sclerosis (RMS), a more common form of the disease, and will submit data from three pivotal Phase III studies to the FDA in the first half of 2016.