Dear Joe,
CONGRATULATIONS!
The FDA Approval of Gilenya(TM) is a milestone in the MS community.
Novartis (NVS) heard the outcry from MS patients, care partners, nonprofits and neurologists; Novartis heard the outcry and listened carefully.
What makes the approval even more exciting is that Gilenya(TM) [FTY720, Fingolimod, Gilenia] is approved for reduction in relapses and in slowing disability progression. While Gilenya is approved for relapsing MS, we are excited about the potential that Gilenya may hold in progressive forms of MS as well (and we await the conclusion of the PPMS trial).
The REMS (Risk Evaluation and Mitigation Strategy) is gentler than we ever could have expected, but this will of course be further clarified in the future.
Novarti's press release was at 7:00 AM CET (GMT +1) and we first broke the news less than 30 minutes later:
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
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