Rebif approved for early use in MS
pharmafile | January 26, 2012 | News story | Sales and Marketing | MS, Merck KGaA, Merck Serono, Rebif
The European Commission has approved an indication for multiple sclerosis treatment Rebif that treats early signs of the condition.
This EC approval is for the use of Rebif 44 micrograms three times weekly in patients who have experienced a single demyelinating event, an early sign of the disease, and who are at high risk of converting to MS.
The approval is based on results from the REFLEX study, which demonstrated Rebif’s safety and efficacy in patients who are at a high risk of developing MS.
Dr Annalisa Jenkins, head of global drug development and medical at Merck Serono, said: “Multiple sclerosis has an initial stage when clinical manifestations are not pronounced but irreversible neurological damage is taking place. Throughout the European Union, neurologists will now be able to prescribe Rebif for patients with early signs of this devastating disease.”
Rebif (interferon beta-1a) is one of the leading beta-inteferon brands, with 2011 sales of around $2.5 billion. But its position is coming under attack from a wave of new MS treatments, such as Sanofi’s Phase III candidate Lemtrada.
A head-to-head between the two drugs carried out by Sanofi put Lemtrada ahead, but Merck Serono’s investment in new research will help it stay ahead for the immediate future.
Another significant competitor in the MS marketplace is Novartis’ oral treatment Gilenya, which was launched last year. However, the new drug is currently subject to an EMA safety review following concerns over its effects on the heart.
The Rebif REFLEX study was carried out over two-years and comprised 517 patients considered at risk of developing MS, due to a recently experienced isolated demyelinating event (e.g. optic neuritis, myelopathy or brainstem syndrome).
Participants were randomised to receive either 44 micrograms three times weekly, once weekly, or placebo as a subcutaneous injection for a period of two years, or up to the time when they experienced a second attack leading to a diagnosis of clinically definite MS.
A three-year double blind extension of the REFLEX study, called REFLEXION, is currently ongoing in order to provide long-term follow-up data.
Brett Wells
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