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First oral MS treatment approved in US

Novartis has gained FDA approval for Gilenya (fingolimod), its novel oral first-line multiple sclerosis treatment

Swiss company Novartis has gained US Food and Drug Administration (FDA) approval for Gilenya (fingolimod) 0.5mg daily, a novel oral first-line therapy for relapsing forms of multiple sclerosis (MS), which has been shown in trials to reduce the frequency of relapses and reduce the risk of disease progression.

The approval for fingolimod, which is also known as FTY720 and was previously branded Gilenia, was based on data from more than 4,500 patient-years of treatment in more than 2,600 trial participants. This represents the largest MS clinical trial programme submitted to the FDA to date.

The trials showed that, at one year, daily treatment with Gilenya 0.5mg reduced relapses by 52 per cent and disease activity as measured by brain lesions to 1.6 from 2.6, compared with a commonly prescribed MS treatment (intramuscular interferon beta-1a). At two years, relapse rate was reduced by 54 per cent and risk of disability progression by 30 per cent compared with placebo.

Fingolimod is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. Fingolimod's novel mechanism is unknown, but it is thought to work by reducing the immune system's attack on the central nervous system (CNS) by retaining lymphocytes in the lymph nodes, which is reversible if fingolimod treatment is stopped.

"Through a novel mechanism of action, Gilenya can significantly improve clinical outcomes among patients with relapsing forms of MS," said Fred Lublin, MD, Saunders Family Professor of Neurology, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine. "Gilenya provides significant efficacy and manageable safety when used in accordance with approved labelling, making it a valuable advancement for relapsing MS patients and the physicians who treat them."

Side-effects of fingolimod include bradycardia, infections, macular oedema and respiratory and hepatic problems, as well as headache, flu, diarrhoea, back pain, abnormal liver tests and cough. Fingolimod's US approval is accompanied by a Risk Evaluation and Mitigation Strategy (REMS), which includes a medication guide for patients, a letter and safety information guide for healthcare providers and a five-year post-authorisation safety study to be conducted by Novartis.

Fingolimod is the first oral therapy indicated for relapsing forms of MS to be made available in the US. Novartis is actively pursuing approval for fingolimod around the world. The drug was submitted to the European Medicines Agency (EMA) for review in December 2009.

"Datamonitor expects widespread use as a first-line therapy, given the high efficacy, convenience and less invasive administration, and forecast Gilenya to capture seven major market sales of $2.4bn in 2019," said Trung Huynh, healthcare analyst at business information provider Datamonitor.

Other oral MS therapies are currently under investigation, including Teva's laquinimod and Merck Serono's Movectro (cladribine), which was approved in Russia and granted FDA priority review in July 2010.

22nd September 2010

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