Roche and Genentech receive priority review of MS drug from FDA
US regulators are conducting a priority review of Roche/Genentech’s experimental multiple sclerosis therapy Ocrevus, which some believe has the potential to transform treatment of the disease.
Ocrevus is an investigational, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell, that is believed to be a key contributor to nerve cell damage, which can lead to disability in people with MS.
Data from the OPERA I and OPERA II Phase III trials involving patients with relapsing MS, which affects around 85% of people at time of diagnosis, found that the drug beat Rebif in reducing the three major markers of disease activity during a 2 year timescale.
The trials showed a 46% and 47% reduction in the annualised relapse rate, and a 43% and 37% risk reduction in confirmed disability progression for 12 weeks compared with interferon beta-1a.
In the Phase III ORATORIO trial in people with primary progressive MS, a form of the disease that features worsening symptoms of which there is no approved treatment, Genentech’s biologic significantly decreases the progression of clinical disability by 24% versus a for at least 12 weeks (the primary endpoint), and by 25% over 24 weeks (a secondary endpoint).
“Ocrevus is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS,” noted Sandra Horning, Roche’s chief medical officer and head of Global Product Development.
“We are pleased by the FDA’s decision to classify their review of the BLA as priority because we believe Ocrevus has the potential to help people living with either of these two forms of MS.”
The drug is also the first investigational medicine to gain Breakthrough Therapy Designation from the US FDA multiple sclerosis, a decision is expected by Dec 28 2016.