Novartis MS drug steals march over Merck rival
pharmafile | January 24, 2011 | News story | Sales and Marketing | Cladribine, MS, Merck KGaA, Novartis, fingolimod, gilenya, multiple sclerosis
Novartis’ oral multiple sclerosis Gilenya could be on the European market in just three months after winning the backing of key European regulatory advisors.
Gilenya (fingolimod) has been recommended by the CHMP for patients with highly active relapsing-remitting MS after treatment with injectable beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.
The positive opinion from the CHMP will now be considered by the EMA with a final decision expected in April.
On the same day, the CHMP confirmed its initial verdict not to recommend Merck Serono’s oral MS drug cladribine, after the German pharma company requested its ruling on the drug be re-examined.
This is a major blow to the German pharma firm as cladribine has already experienced a series of delays with the FDA, which has held back its final decision on the drug until next month.
The CHMP’s decision for Novartis’ Gilenya is based on recent phase III trials that showed it was superior to interferon beta-1a IM, a commonly prescribed treatment, reducing relapses by over a half (52%) after a year.
A two-year, placebo-controlled study also demonstrated that the drug significantly reduced the risk of disability progression.
John Golding, president of the European Multiple Sclerosis Platform – an umbrella organisation for nearly 40 European MS societies, said: “More than 500,000 people in the EU live with MS, a debilitating neurological condition that involves an unpredictable, life-long progression of complex symptoms.
“The first available oral MS treatment that offers significant efficacy for appropriate patients is a welcome alternative.”
In further positive news for Novartis, Gilenya has also just gained approval in two further markets.
“Following the approval of Gilenya in the United States and in Russia, we are proud that we can now offer this effective, once-daily oral treatment to patients in Switzerland and Australia,” said David Epstein, division head of Novartis Pharmaceuticals.
“Novartis has an excellent track record of securing access to innovative medicines for patients and we are committed to assuring access to Gilenya for eligible patients around the world.”
Ben Adams
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