European regulators have given a green light to the use of Schering AG’s Betaferon in the early stages of multiple sclerosis, thereby providing people who suffer just one clinical event suggestive of the condition access to the drug.
The move follows a recommendation last month by the European Commission’s Committee for Medicinal Products for Human Use (CHMP), which backed approval of Betaferon (interferon beta-1b) for ‘emerging’ MS based on the positive results of the BENEFIT trial.
Data from the study, which have also been submitted to the US Food and Drug Administration for consideration, showed that giving the agent in the early stages of the disease cut the risk of developing full-blown MS by 50% compared to placebo.
The European thumbs up is certainly good news for the firm, which is trying hard to lift the profile of its top-selling drug - already marketed for treat patients with relapsing forms of MS - in the face of increasing competition in the market from rival beta interferon products and newer agents.
With this approval, Betaferon is now the only high-dose, high-frequency therapy cleared for the treatment of the earliest stages of the disease. And this could give the agent a significant advantage over its competitors, as “effective treatment early in the course of the disease is important since studies have shown that irreversible nerve damage and brain atrophy can occur in the earliest stages of MS,” explained David Bates, Professor of Clinical Neurology at the University of Newcastle upon Tyne and Chairman of the MS Forum.
Moreover, use in early-stage disease could help Betaferon compete against its rivals in the MS arena by making it more likely to be used in newly-diagnosed patients. These would likely be maintained on the drug as their disease progressed, rather than switched to an alternative.