It was announced on December 20, that the long awaited drug Ocrevus™, would be delayed in approval from the FDA. We have been anticipating this new MS disease modifying therapy to be approved especially because it is the first disease modifying therapy to be shown to be effective for primary progressive MS (PPMS), and this delay is disappointing.
Pharmaceutical company Genentech issued a very short statement about the delay –
“Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) of OCREVUS™ (ocrelizumab) to March 28, 2017. The extension is the result of the submission of additional data by Genentech regarding the commercial manufacturing process of OCREVUS, which required additional time for FDA review. The extension is not related to the efficacy or safety of OCREVUS.”
I have written about ocreluzimab (brand name OCREVUS) over the past few years, including this article from February 2016, Ocrevus On Fast Track for PPMS, and its fast-track designation with the FDA for an approval hearing to have been held in December. I’ve reached out to these same company representatives for further explanation on this delay, and was able to discuss my questions with Dr. Peter Chin, Principal Medical Director for Genentech-Roche Global Neuroscience Development.
“We are very confident about our data. We are not concerned, and this is just a matter that the FDA needs more time (for their review). We will work as quickly as possible to answer their questions,” said Dr. Chin.
After our talk, I better understand the FDA approval process. I had pictured that a company submits all of their information, the FDA panel of experts reviews that information, and then makes a decision. Dr. Chin says that instead, it is really an ongoing series of questions and answers as reviewers go through the submitted materials and it is not at all out of the norm for there to be a lot of back-and-forth exchanges between a company and the FDA while points are clarified and better understood.
Dr. Chin says to his knowledge, Genentech Roche has no problems with their commercial manufacturing of Ocrevus, but this delay comes from more questions from FDA reviewers about that process. He also agreed that in his role as Medical Director for ocreluzimab, he would not be involved in the manufacturing side. Dr. Chin declined to speak to the specific questions the FDA had posed about ocreluzimab’s manufacturing process, because this drug is still under review.
In their coverage of the Ocrevus, FierceBiotech points out “A number of Big Pharmas, including most notably AstraZeneca … have been hit with major delays over manufacturing issues for their meds, a situation that has contributed to 2016 seeing a much lower level of approvals when compared to the past two years.”
The original December 2016 FDA date was set by this government agency and they have now said they expect to be finished with their review no later than March 28, 2017. Genentech Roche spokespersons, including Dr. Chin, note that this review could take place before March, and are hopeful that is the case. They are prepared to get this new disease modifying treatment option to MS providers quickly once final approval is received.
In that same official press statement about this delay, Genentech Roche talks of their continued faith in this drug-
“We strongly believe in the potential of OCREVUS as a new therapeutic option for both people with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS),” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are working closely with the FDA during their review and are committed to bringing this innovative medicine to the over 400,000 people with MS in the U.S. living with this disabling disease as quickly as possible.”
Company officials are excited the New England Journal of Medicine, viewed by most medical researchers as the premiere publication for clinical studies, published two peer reviewed articles in late December about the results of the ocrelizumab studies – OPERA and ORATORIO. These were separate studies on the use of this drug in these two distinctly different forms of MS.
It is the use of ocrelizumab in PPMS that has so many of us with MS excited because until this point there has been no FDA approved treatment for this form of multiple sclerosis which affects approximately 10-15% of the MS population. In Genetech’s relesase Positive Phase III Results of Genentech’s Investigational Medicine Ocrevus™ (Ocrelizumab) Published in New England Journal of Medicine,they write:
“OCREVUS is the first and only investigational medicine to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study,” said Xavier Montalban, M.D., Ph.D., Chair of the Scientific Steering Committee of the ORATORIO study and Professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, Barcelona, Spain. “Over the last decade, other molecules have tried and failed to demonstrate efficacy for PPMS, so the positive results for OCREVUS mark an important step in our understanding of this highly disabling form of the disease.”
“We are very disappointed for the patients” in this delay, Dr. Chin said, but he remains confident that once Genentech gets through all of the FDA panel’s questions, Ocrevus will be approved. I hope there will be no further delays and I will be writing about that news soon.
Wishing you well,