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Novartis’ Gilenya fails in difficult-to-treat form of MS

Drug no better than placebo as a treatment for primary progressive multiple sclerosis
Novartis MS drug Gilenya fingolimod

There was disappointment for the multiple sclerosis (MS) community today as Novartis posted discouraging data for one its drugs in a difficult-to-treat form of the condition.

Results from the phase III INFORMS study demonstrated that Gilenya (fingolimod) was no better than placebo in patients with primary progressive multiple sclerosis (PPMS), a distinct form of the disease that is defined by a steady worsening of neurologic functioning.

PPMS is thought to affect 10% of MS patients and differs from the more common relapsing remitting form of MS (RRMS) that sees patients experience acute attacks or exacerbations and periods of remission.

Gilenya was approved in RRMS in 2010, revolutionising treatment in the area as the first oral drug to treat the condition.

It has lived up to its high expectations, ranking in the top 50 biggest selling pharmaceutical products for 2013 with sales of $2.2bn, although more oral RRMS treatments have now hit market, including Sanofi's Aubagio (teriflunomide) and Biogen Idec's Tecfidera (dimethyl fumarate).

Novartis was hoping that Gilenya would provide a similar breakthrough in PPMS, although the data from INFORMS puts these ambitions on hold.

The news is particularly exasperating considering the only drugs available for the condition tackle its symptoms rather than the underlying cause as Gilenya is intended by interacting with damage-causing cells residing in the patient's central nervous system.

The failure of Gilenya in this indication have led researchers to suggest that PPMS and RRMS have different underlying mechanisms, meaning that other approved RRMS treatments could face similar disappointment if trialled in PPMS.

"We understand this news is very disappointing for those affected by PPMS and involved in its management,” said Vasant Narasimhan, global head of development at Novartis' pharmaceuticals division.

“While PPMS is a focus of the MS community, relatively little is known about the disease so finding effective treatments remains a challenge. We will actively work with the MS community to review and analyse the INFORMS results to help increase the understanding of this devastating disease.”

Article by
Thomas Meek

1st December 2014

From: Sales

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