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Posted by on Jan 27, 2010 in FDA, Neurology, Pharma

Huh? When? Novartis Submitted NDA for Fingolimod in December

Huh? When? Novartis Submitted NDA for Fingolimod in December


While plowing through Novartis’s newly released financial report for 2009, I found this quiet gem: the “dossier” for Gilenia, the proposed trade name for fingolimod or FTY720, was submitted to the FDA and the European Medicines Agency in December. Now by “dossier,” I assume that the company means its new drug application for the investigational compound; certainly the media are reasonably interpreting dossier as NDA.

This under-the-radar news of the NDA submission comes as a surprisenot because the fingolimod NDA was submitted (that was actually expected back in December), but because the news was provided so sotto voce.* I merely stumbled across the information while I was looking for more dirt on the company’s recent Trileptal plea agreement.

And just in case I missed news of the NDA submission back in December (despite blogging semi-feverishly about the race between Novartis and Merck Serono to market the first-ever disease-modifying pill for multiple sclerosis), I rechecked the Google news archives. Nope, nothing.**

So the question is: Why no big announcement of the Gilenia NDA submission, Novartis? In typical fashion, Merck Serono trumpeted the submission of its NDA for the fast-track approval of oral cladribine in September.

Perhaps the answer has something to do with the FDA’s December announcement that it refused to file Merck Serono’s cladribine NDA. But I have to admit: I’m kind of flummoxed.

* Not to mention, a month after it happened.

** Although, last week, both Dow Jones and Reuters reported Novartis’s NDA submission of fingolimod. I am mentally flaggellating myself for missing these reports.

bmartin (1130 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.

1 Comment

  1. Did you find out anything about the oral MS drugs. My neurologist is uncertain when it will be approved or why it hasn’t. Will it likely be approved in Europe first? (I could go there for it) What is the holdup?