Betaseron Approved In Europe For Secondary-Progressive MS
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Betaseron Approved In Europe For Secondary-Progressive MS

MONTREAL, QC -- April 16, 1999 -- Berlex Laboratories’ Betaseron(R) (Interferon beta-1b) has been approved for use in Europe among patients suffering from secondary-progressive multiple sclerosis (SPMS).

This form of the disease affects approximately 40 percent of MS sufferers and, up to now, was untreatable.

Approval by the Commission of the European Communities came within three months of a published study which appeared in the journal The Lancet in November 1998. The study demonstrated the benefits of Betaseron among patients with SPMS and found that Betaseron: could delay the progression of the disease by nine to 12 months; reduce by approximately 22 percent the proportion of patients with confirmed disease progression; and reduce by one third the number of patients who required a wheelchair.

The results of the study were particularly striking because a benefit over placebo was detected after only 12 months of treatment. Originally, the study was planned for three years but it was halted early in 1998 because a special review board supervising the trials concluded that the benefits of treatment were so clear-cut that it would not be ethical to continue to keep half the patients on placebo for another year.

Left untreated, SPMS patients would inevitably develop symptoms resulting in functional loss in various body systems including speech, vision and movement. In the worst cases, MS causes partial or complete paralysis.

Related Links: Betaseron, Berlex Laboratories

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