Novartis' Gilenya is a giant leap closer to European approval following a thumbs up from regulatory advisors, making it likely that the drug will become the first MS pill available in the region.
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended that Gilenya (fingolimod) 0.5 mg daily be approved as a second-line therapy in patients with highly active relapsing-remitting multiple sclerosis (MS) despite therapy with beta interferon, or in those who have rapidly evolving severe relapsing-remitting forms of the condition.
Gilenya is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators, thought to work by holding back certain white blood cells in the lymph nodes, which prevents them from reaching the central nervous system where they could potentially cause nerve cell damage. Importantly, its action leaves key immune functions in tact, and the retention of lymphocytes can be reversed if necessary.
The drug's positive recommendation is based on a massive clinical trial programme which showed that it reduced the rate of disease relapse by 54% compared to placebo and cut disability progression by a third, Novartis said. Moreover, Gilenya is the only pill proven to be twice as effective at improving relapse rates as a standard intramuscular injection with interferon _-1a, it added.
Various other companies are developing rival oral therapies for MS - most notably Merck KGaA, which suffered a setback after US regulatory advisors voted against approving its Movectro (cladribine) last week - but analysts are still predicting Gilenya to capture the lion's share of the market with annual peak sales estimates ranging from $2.4 billion to more than $5 billion a year if approvals continue as expected.
Gilenya won marketing clearance in the US and Russia last September, and if European regulators follow suit a green light is expected in about three months' time, Novartis said.