Betaferon approved for early stage MS - in Europe

A board to discuss the Multiple Sclerosis modifying drug Betaseron

Betaferon approved for early stage MS - in Europe

Postby bromley » Wed Jun 07, 2006 2:14 am

Given the re-approval of Tysabri, it's not surprising that the CRAB manufacturers are looking for other ways to boost their sales.


Schering says MS drug Betaferon approved in EU for early-stage treatment

Schering AG said its multiple sclerosis drug Betaferon has been approved in Europe as a first-line treatment for the earliest stages of multiple sclerosis.

The approval is valid in all 25 European member states as well as in Iceland and Norway.

Schering said this new label allows for the treatment of the majority of patients at risk of getting multiple sclerosis, and includes patients who have signs only suggestive of MS.

Schering said the 'approval provides an important treatment option for patients to reduce the risk of developing clinically definite MS (CDMS), and the chance to delay the progression of the disease'.

The approval is based on the BENEFIT study, which showed that Betaferon treatment in the early phase of the disease reduced the risk of developing clinically definite MS by 50 percent compared to placebo.

'The results of the BENEFIT trial show that Betaferon can substantially slow down the course of MS in early patients, especially those at the earliest stage of the disease, when it has the greatest impact", said Darlene Jody, head of specialized therapeutics at Schering.

The drug, marketed under the name Betaseron in the US, is currently also under review for use in early stage MS there, and the Food and Drug Administration is expected to make a decision on approval later this year.

Betaferon was first approved by the EU in 1995.

This year, Schering is targeting high single-digit sales growth for the drug.

Source: AFX News Copyright AFX News Limited 2005. All rights reserved.
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