Novartis Says MS Drug Gilenya Consistently Reduces Brain Volume Loss

Swiss drug giant Novartis AG (NVS: Quote) on Tuesday confirmed that its multiple sclerosis drug Gilenya (fingolimod) has shown consistent and sustained efficacy, with the number of patients treated increasing to over 63,000.

Based on up to seven years of clinical trial experience, including Phase II and III, and over two years of real-world use, Novartis noted that Gilenya, licensed from Japan's Mitsubishi Tanabe Pharma Corp. (MTZXF.PK), is the only approved MS treatment shown to consistently decrease brain volume loss.

According to the company, brain volume loss is the best magnetic resonance imaging or MRI correlate of long-term disability.

New data presented at the recent 65th Annual Meeting American Academy of Neurology showed that Gilenya reduced the rate of brain volume loss by about one-third compared to Avonex (interferon beta-1a IM), a commonly prescribed treatment, or placebo in patients with relapsing MS.

The low rate of brain volume loss with Gilenya sustained for up to four years in Phase III studies and for up to seven years in patients after completing a Phase II study.

Data has also shown significant efficacy with Gilenya in reducing relapses and slowing of six-month disability progression sustained at four years, the company added.

Novartis said the drug is now approved in 70 countries, and there is approximately 73,000 patient years of exposure.

David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG, said, "As the first once-daily oral MS therapy, we are pleased Gilenya has played such an important role in addressing unmet medical need in the MS community in the two years following initial approvals. Our growing experience reinforces Gilenya's high efficacy and very good tolerability profile and Novartis remains committed to ensuring eligible patients have access to Gilenya."

by RTT Staff Writer

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Novartis Says MS Drug Gilenya Consistently Reduces Brain Volume Loss