Boosts prospects for oral drug as competitors emerge
New data from two phase III trials of Novartis' oral multiple sclerosis (MS) therapy Gilenya suggest the drug has an early impact in the disease on both relapse rate and brain volume loss.
The new analyses - from the FREEDOMS and FREEDOMS II trials of Gilenya (fingolimod) - show that Novartis' drug was better at placebo on extending the time to first confirmed relapse, with the difference apparent within three months of starting therapy.
The differences between Gilenya and placebo became significant by day 82 in FREEDOMS and day 64 in FREEDOMS II, respectively, according to Novartis.
Moreover, data from the FREEDOMS trial showed that patients treated with Gilenya had a 35 per cent reduction in brain volume loss compared to placebo at six months, when the first magnetic resonance imaging (MRI) scan was taken. In FREEDOMS II the difference was 39 per cent.
Meanwhile, fresh results from other studies indicate that adherence rates for Gilenya are higher than for injectable MS therapies based on interferon beta, while Novartis provided an update on safety in 3,500 patients indicating a safety profile "generally consistent with previous results".
The latter finding is an important endorsement of the safety of Gilenya, which had its labelling updated earlier this year to contra-indicate its use in patients with a history of heart disease or stroke.
The new analyses were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Gilenya was the first oral drug to be launched for MS on the market last year, and its patient-friendly dosing helped it garner sales of $494m in 2011 as a whole, and it is well on the way to blockbuster status with revenues of $530m in the first half of 2012.
Latterly it has been joined in the market by Sanofi's Aubagio (teriflunomide), and other orally-administered rivals such as Biogen Idec's BG-12 are also nearing the market. With the market no longer to itself, Novartis will rely on new data such as that presented at ECTRIMS to differentiate its product.
"The new analysis of phase III data shows a significant early effect of Gilenya on relapses and MRI measures, and further supports its role as a valuable treatment option for relapsing-remitting MS," commented Ludwig Kappos, chair of neurology at the University Hospital in Basel, Switzerland.
"Understanding the onset of efficacy is an important consideration in the treatment of MS as early effective treatment may improve patient outcomes," he added.