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Merck Serono’s Rebif approved in EU for early-stage MS

Boost for multiple sclerosis treatment in increasingly competitive market

Merck Serono has been approved in the EU to expand the indications for its multiple sclerosis (MS) treatment Rebif to include patients in the early stages of the disease.

The European Commission has said Rebif can be used in the treatment of patients who have experienced a single demyelinating event but are at high risk of developing full-blown MS.

The approval was based on the results of the phase III REFLEX study, which showed that Merck's drug could delay the onset of conversion to MS in these patients and was safe.

The study used a Rebif dose of 44mcg three times a week, in a human serum albumin-free formulation, and showed that the probability of conversion to MS over two years was 86 per cent in the placebo group and 62 per cent for Merck's drug.

“MS has an initial stage when clinical manifestations are not pronounced but irreversible neurological damage is taking place,” said Dr Annalisa Jenkins, head of global drug development and medical at Merck Serono.

“Throughout the EU, neurologists will now be able to prescribe Rebif for patients with early signs of this devastating disease,” she added.

The expanded indication is a boost for Merck Serono as it faces an increasingly competitive market for Rebif.

Rivals include Novartis' recently launched oral MS drug Gilenya (fingolimod) – currently subject to a safety review in the US and Europe – and also from newer injectables such as Sanofi's Lemtrada (alemtuzumab).

The latter recently beat Rebif in a head-to-head study and could reach the market within the next 18 months.

Meanwhile, in Europe the EMA is currently carrying out a consultation on a route to commercialisation for biosimilar interferon beta products, which could post a medium-term threat to Rebif and other first-generation products, Biogen Idec's Avonex and Bayer's Betaferon.

26th January 2012

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