FDA gives Roche MS drug breakthrough status
Roche subsidiary Genentech has been awarded US Food and Drug Administration (FDA) Breakthrough Therapy Designation for its drug Ocrevus (ocrelizumab) for the treatment of primary progressive multiple sclerosis (PPMS).
There are currently no approved treatments for PPMS, a severe form of MS characterised by gradually worsening symptoms and typically without distinct relapses or periods of remission.
“Ocrelizumab is the first investigational medicine for MS to be granted Breakthrough Therapy Designation by the FDA,” says Sandra Horning, chief medical officer and head of Global Product Development. “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.”
Breakthrough Therapy Designation is given to medicines that show promise in treating serious diseases or conditions that lack treatments, in order to expedite the FDA approval process. In the case of ocrelizumab, Genentech provided data from a Phase III study, which showed treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo.
The drug works by selectively targeting CD20-positive B cells- a specific type of immune cell thought to play a key role in myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS.
Genentech says it plans to pursue marketing authorisation 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.
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