Genentech, a member of the Roche Group, announced in a February 16 press release that the experimental therapy ocrelizumab has been granted ‘Breakthrough Therapy designation’ by the US Food and Drug Administration (FDA) for the treatment of people with primary progressive MS.
This designation means that the FDA’s assessment process to determine whether a new drug should be licensed for marketing will be fast tracked. All of the pre-clinical and clinical trial data will still be included in the assessment as for any new drug, however, the drug will be prioritised for a faster route through the FDA’s assessment process. There are currently no approved treatments now for PPMS, a debilitating form of the disease marked by steadily worsening symptoms.
For more information on this, please visit MS Research Australia's commentary here.