SM Hírek : Merck KGaA receives EMEA recommendation of new Rebif formula to treat MS |
Merck KGaA receives EMEA recommendation of new Rebif formula to treat MS
2007.06.28. 18:56
The CHMP's recommendation will now be considered by the EU Commission, which will deliver the final decision on the granting of the market authorization.
Rebif is a disease-modifying drug used to treat relapsing forms of multiple sclerosis and is simlar to the interferon beta protein produced by the human body.
A Phase III study showed that the new formulation leads to a rate of injection-site reactions in MS patients treated with Rebif over one year that is three times lower, compared with historical data from previous trials.
Rebif, which was approved in Europe in 1998 and in the US in 2002, has been shown to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity.
It is not approved for the treatment of chronic progressive multiple sclerosis.
Multiple sclerosis is a chronic, inflammatory condition of the nervous system and affects up to 2.5 mln people worldwide.
maria.sheahan@thomson.com mas/jag/mas/jag COPYRIGHT Copyright AFX News Limited 2007. All rights reserved.
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