The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche’s investigational medicine, ocrelizumab (OCREVUSTM), for the treatment of primary progressive multiple sclerosis (PPMS).
The Swiss drug manufacturer said that ocrelizumab is the first investigational medicine to receive breakthrough therapy designation in multiple sclerosis (MS).
Ocrelizumab is an investigational, humanised monoclonal antibody that is designed to selectively target CD20-positive B cells.
Based on preclinical studies, ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, thereby protecting important functions of the immune system.
The breakthrough status was based on the results of a Phase III trial called Oratorio.
The trial results have shown that treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo.
Roche global product development head and chief medical officer Dr Sandra Horning said: "With no approved treatments for primary progressive MS, ocrelizumab has the potential to address an important unmet need.
"We are committed to working with the FDA to bring ocrelizumab to people with primary progressive MS as quickly as possible."
The company said that there are currently no approved treatments for PPMS, a debilitating form of MS characterised by steadily worsening symptoms and without distinct relapses or periods of remission.
Roche plans to pursue marketing authorisation for both PPMS and relapsing multiple sclerosis (RMS), a more common form of the disease.
The company will submit data from three pivotal Phase III studies to global regulatory authorities in the first half of this year.
