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Timothy L. Vollmer, MD
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Wednesday

 

Still Waiting on Ocrevus (Ocrelizumab): VIDEO





















Several months ago I wrote a blog on my personal website about Ocrevus, the first drug that’s designed specifically to treat primary progressive, as well as remitting, multiple sclerosis. The clinical trials for Ocrevus posted excellent results. The buzz in the medical community was good, and it was hoped that Ocrevus would receive final approval for use in the U.S. by the end of this year.

Wednesday night the CBS Evening News broadcast a very positive report about the drug.

Alas, there will be no final approval by year’s end. The U.S. Food and Drug Administration extended its review of Ocrevus the day before that CBS report was broadcast. Genentech, the company that makes the drug, says the FDA has now set March 28 for its review of the Ocrevus license application. According to Genentech, the delay came because the FDA asked for additional information about the manufacturing process for the drug. The extension, Genentech wrote in a news release, is not related to the efficacy or safety of Ocrevus.

“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, MD, 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.”

Well, let’s hope so. While I was researching Lemtrada infusions, (and I’m happy to say that I continue to do well as I approach two weeks after my Round 1 infusions), I ran into a lot of MS patients who would like to be receiving that drug. For them March 28, and hopefully final FDA approval of Ocrevus, can’t come soon enough.

This is my final column for 2016. I hope your holiday, whichever you celebrate, is joyous and that the new year brings better health to us all.

Story Source: The above story is based on materials provided by MULTIPLESCLEROSISNEWSTODAY
Note: Materials may be edited for content and length

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