#MSresearch #Primary Progressive MS Good news
GoodNews for PPMSers for a change. The FDA has agreed to fasttrack the accessment of ocelizumab and its trade name is born
Breakthrough Therapy designation is a United States Food and Drug Administration expedited drug development tool, which allows the FDA under Section 902 of the July 9, 2012 Food and Drug Administration Safety and Innovation Act, to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.
A breakthrough therapy designation can be assigned to a drug if "it as a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development
Ocrelizumab is the first investigational medicine to receive Breakthrough Therapy Designation in multiple sclerosis (MS)
Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM) for the treatment of people with primary progressive multiple sclerosis (PPMS). There are currently no approved treatments for PPMS, a debilitating form of MS characterised by steadily worsening symptoms and typically without distinct relapses or periods of remission.
Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The designation is based on positive results from the pivotal Phase III study (called ORATORIO), which showed treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo. Top-line results were presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015.
Roche 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 global regulatory authorities in the first half of 2016.
OCREVUS is the proprietary name submitted to global regulatory authorities for the investigational medicine ocrelizumab.
p.s. This corrects my mistake calling it OCREVUSTM which was a slip up after a cut and paste removed the superscript from trade mark (TM).....LoL
This is great news however it is not a done deal and we will have to wait and see whether there is a green light for all of primary progressive MS or whether they will be pinned back to "active" primary progressive MS and whether there are any other issues that the regulators come up with once they get to see the full data package.
Who makes up these names?.....OCREVUSTM...Indeed