Gilenya approved as new frontline MS treatment
pharmafile | September 22, 2010 | News story | Research and Development, Sales and Marketing | Cladribine, FDA, Novartis, gilenya
Novartis’ new multiple sclerosis treatment Gilenya has been approved by the FDA, and is set to significantly alter the way the disease is treated.
Gilenya (fingolimod) has been approved as a first line treatment for relapsing forms of MS, and looks likely to seize market share from existing injectable beta interferon drugs.
Analysts predict the drug could hit peak annual sales of around $2.5 billion.
An oral drug, Gilenya is not only more convenient for patients than injections, but clinical trials also suggest it could also cut relapses compared to beta interfon. A key study showed it cut relapses by 52% at one year compared with interferon beta-1a IM.
A separate two-year, placebo-controlled study showed that Gilenya significantly reduced the risk of disability progression.
Novartis says the drug’s safety and tolerability profile has also been proven with over 2,600 patients participating in clinical trials, with some now in their seventh year in trials.
The FDA approval makes it the first oral treatment indicated for relapsing forms of MS available in the US, ahead of rival treatment cladribine from Merck Serono.
“Today is a significant and encouraging day for people with relapsing forms of MS in the US,” said Nicholas LaRocca, vice president of healthcare delivery and policy research at the National Multiple Sclerosis Society.
“A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease.”
Gilenya’s approval was based on the largest clinical trial programme ever submitted to date to the FDA for a new MS drug, and included combined data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity in people with relapsing forms of MS.
“We are proud to have worked successfully with the MS community toward a shared goal of bringing a novel efficacious treatment to people with relapsing forms of MS,” said Trevor Mundel, MD, global head of development at Novartis Pharma.
“We are actively pursuing regulatory approval in Europe and the rest of the world.”
Gilenya is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. In MS, the immune system damages the covering that protects nerve fibres in the central nervous system (CNS), which includes the brain and spinal cord.
Gilenya’s novel mechanism is unknown, but it is thought to work by reducing the immune system’s attack on the CNS by retaining certain white blood cells (lymphocytes) in the lymph nodes. This prevents the white blood cells from reaching the CNS, where they could potentially attack the protective covering around the nerve fibres, resulting in less inflammatory damage to the nerve cells. The white blood cell retention is reversible if Gilenya treatment is stopped.
Merck Serono’s cladribine stole a march on Gilenya in Russia, where it was approved in July, but Novartis’ approval in the all-important US puts it in pole position overall.
Andrew McConaghie
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