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Drug delays conversion to MS

Results from a phase III study into Merck Serono's Rebif has shown it significantly delays conversion to multiple sclerosis

Results from a phase III study into Merck Serono's Rebif (interferon beta 1a) has shown it significantly delays conversion to multiple sclerosis (MS) diagnosed according to the current reference criteria for diagnosis, known as the McDonald criteria.

The two-year international REFLEX study of 517 patients was conducted with the serum-free formulation of Rebif, which was first introduced in 2007 and is now available in all European Union countries, Australia, Canada and Switzerland, as well as a number of countries in Asia, Latin America, Africa and the Middle East. It is not available in the US at present.

The study found that the risk of conversion to MS over two years was reduced by 51 per cent in patients who received Rebif 44 mcg three times a week compared to placebo.

A risk reduction of 31 per cent compared to placebo was observed in patients who received this dose once a week. The probability of conversion to MS over two years was 86 per cent in the placebo group, 62 per cent in patients who received Rebif 44 mcg three times a week and 76 per cent in patients who received a once-weekly administration.

"We are committed to provide treatments that meet the individual needs of people living with multiple sclerosis at the various stages of the disease," said Dr Roberto Gradnik, executive vice president for neurodegenerative diseases at Merck Serono.

"Over the years we have continuously worked on enhancing the product profile of Rebif with new formulations, new injection devices and new clinical data. We are very pleased with these new clinical data as they show that patients in the study with the first clinical signs of multiple sclerosis benefited from treatment with Rebif."

No unexpected adverse reactions were identified. The majority of adverse events comprised mild or moderate flu-like symptoms.

A three-year double blind extension of the REFLEX study, called REFLEXION, has been initiated to provide long-term follow-up data (up to five years).

Rebif is not currently licensed for treating patients with a first clinical event suggestive of MS. 

26th October 2010

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