Novartis’ Gilenia has delivered an impressive performance in a Phase III trial in patients with multiple sclerosis, cutting relapse rates by 62% in treatment-naïve patients and sustaining its effects for more than two years.

Importantly, data from the two-year FREEDOMS study, presented at the American Academy of Neurology annual meeting, also showed that relapse rates were reduced by a significant 44% in patients who had previously been treated with other drugs for MS, highlighting the potential benefit of switching therapies.

In addition, Gilenia (fingolimod) was able to delay the progression of disability by 30% for patients on 0.5mg compared to placebo, and results from an extension study indicate that its benefits to patients last for more than two years, the firm said.

Gilenia is currently being reviewed by regulators on both sides of the Atlantic as a potential first-in-class, once-daily oral therapy for relapsing forms of MS, and this latest batch of clinical data will no doubt add further ballast to the drug’s positive benefit-risk profile.

“These findings reinforce the potential for Gilenia to be a breakthrough therapy option for physicians and people with relapsing forms of MS,” stated Trevor Mundel, global head of development at Novartis. Not only do they demonstrate the drug’s effectiveness irrespective of treatment history and further support both its sustained efficacy for over two years, but also highlight the potential benefits of switching from current standard therapy with interferon beta-1a, he explained.

In addition, the drug seems to have an acceptable safety profile, with rates of infections overall and malignancies comparable between treatment groups, although a slight increase in lung infections - primarily bronchitis - was seen in patients given Gilenia, Novartis noted.

Race to market
Novartis and Merck KGaA are both racing to get the first oral treatment for MS onto the market, but at the end of last year the German drugmaker was hit with a setback after US regulators issued a ‘refuse to file’ letter for its cladribine indicating that the New Drug Application for the drug is incomplete.

However, since Gilenia involves a new active ingredient, the FDA is likely to require an advisory committee meeting and evaluate the firm’s risk management programme, which could result in the agency extending its review at the end of the six-month period and thereby also delay the drug’s path to market.