WELCOME to: 'Stu's Views and MS News' an informational archive provided by MS Views and News

· Key-Note: This blog provides education, information and resources to benefit those affected by Multiple Sclerosis.

· Opt-In at our website (MS Views and News) to receive our globally transmitted Multiple Sclerosis e-newsletter, currently being received in more than (90) Countries.

· Our live MS educational seminars average 67 people per educational program. SINCE our first program in February 2010, we have hosted more than 130 educational programs.

· Visit our Multiple Sclerosis Learning channel on YouTube archived by topic here: www.youtube.com/msviewsandnews

Be Empowered with Beneficial MS Information - ---Visit MS Views and News.org

joomla ecommerce template

View all the resources found on the left side of this blog. Use our 'search by topic' tool, when wanting to find specificinformation.


Monday, December 14, 2009

Could Novartis be first to launch Multiple Sclerosis oral therapy?

Article source: MSRC-UK

FTY720 (Fingolimod) is the first in a new class of disease-modifying treatments called sphingosine 1-phosphate receptor (S1P-R) modulators and has a novel mode of action different from all currently marketed MS therapies.

Novartis AG is jockeying with German drug maker Merck KgaA to deliver the first disease modifying treatment for relapsing forms of multiple sclerosis that can be taken orally, rather than by infusion or injection.

Fingolimod could finally move ahead in the race to market, as the FDA rejected Merck's new drug application for its Cladribine tablet.

On November 30, US regulators issued a "refusal to file letter" to Merck Serono, the US subsidiary. Company spokesman Gangolf Schrimpf told me the FDA preliminary action of the cladribine submission was not an assessment of the efficacy and safety of the compound. Nonetheless, the agency obviously felt the deficiencies in the filing were material enough - scientific or legal - to delay its formal review of the tablet.

Initial results from Novartis' two-year FREEDOMS FTY-720 study show that once-daily oral fingolimod reduced the relapse rate by 54 percent for the 0.5 mg dose in patients with relapsed MS. Novartis looks to file its new drug application with the FDA within next few months, followed fast track approval and launch in summer 2010.

Continue to read , direct from the MSRC-UK website


Register at www.msviewsandnews.org to keep up-to-date with MS news and enable you to receive our weekly MS related e-newsletter


1 comment:

Erin said...

Not as good as Tysabri in regards to efficacy, but better than the injectibles. Good to know!