First oral MS pill approved in Europe
pharmafile | March 21, 2011 | News story | Sales and Marketing | MS, Novaris, fingolimod, first oral multiple sclerosis drug, gilenya, multiple sclerosis
Novartis’ Gilenya has become the first oral multiple sclerosis drug to be approved in Europe.
Gilenya (fingolimod) is now licensed for patients with highly active relapsing-remitting multiple sclerosis (RRMS) who have already received beta interferon.
The drug is also approved for patients with rapidly evolving severe RRMS.
Gilenya was approved in Russia and by US regulators in September last year, and analysts predict the drug could reach peak year sales of around $2.5 billion.
Trials results suggest it could be more effective at cutting relapses compared to the commonly prescribed injectible treatment beta interferon and, as an oral drug, Gilenya will be more convenient.
But it does have a number of common, potentially serious side effects, including reduced white blood cells, irregular heart rhythm and gastroenteritis, and because of this Novartis will be required to implement a pharmacovigilance plan for Gilenya.
The drug was licensed from Mitsubishi Tanabe Pharma Corporation and is the first in a new class of treatments called sphingosine 1-phosphate receptor (S1PR) modulators.
The novel mechanism of the drug is thought to work by reducing the immune system’s attack on the central nervous system (CNS) by retaining certain white blood cells in the lymph nodes which results in less inflammatory damage to the nerve cells.
David Epstein, division head of Novartis Pharmaceuticals, said: “Today’s announcement marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients.
“Gilenya has been in clinical development for MS since 2003 and we are grateful for the commitment of those involved, especially the trial participants, who have contributed significantly to the development of this novel medicine.”
In one key study showed Gilenya cut relapses of MS by 52% at one year compared with interferon beta-1a IM.
This will be a further blow to Merck KGaA who had been in competition with Novartis to bring its oral MS drug Movectro (cladribine) to the EU, but pulled its application last month due to adverse side effects.
The news for Merck got worse this month when the FDA turned down its US application for much the same reasons, leaving Novartis with an clear run at the oral MS market with Gilenya.
Ben Adams
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