Gilenya approved in Russia, awaits FDA decision
pharmafile | September 16, 2010 | News story | Sales and Marketing | Cladribine, Gilena, MS
Novartis has won approval for its MS drug Gilenya in Russia but still awaits the FDA’s decision on its fate in the crucial US market.
This is the first approval for the oral form of fingolimod, marketed at Gilenia outside of Russia, and the drug has won a licence to treat patients with relapsing remitting multiple sclerosis.
In June, an advisory committee of the FDA unanimously recommended approval of the drug and a decision is expected later this month.
If approved, Gilenia would steal a march in the US over Merck Serono’s rival MS treatment cladribine.
Cladribine was given a priority review by the FDA back in June but a decision on the drug will not be made until early 2011.
Merck’s treatment has suffered a series of setbacks in the past year including a ‘refuse to file’ from the FDA back in November 2009 that required the German firm to resubmit the drug back in June.
Both drugs have been in a race to market with cladribine gaining approval in Russia in July and in Australia last week.
Both firms are in a race to have the first oral MS therapy to market and potentially snatch the mantle of standard MS treatment away from the intravenous form of interferon beta.
The MS market could yield strong sales for either drug, with Merck Serono’s own interferon beta treatment Rebif making 1.5 billion euros in revenue last year.
Gilenia is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators and works by providing selective and reversible retention of lymphocytes in lymph nodes, preserving key immune functions and flexibility in patient management.
Gilenia is also under review by European regulators at the EMA as well as a number of other health authorities worldwide.
Ben Adams
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