People who suffer just one clinical event suggestive of multiple sclerosis should have the option of treatment with Schering AG’s Betaferon, according to the European Commission’s Committee for Medicinal Products for Human Use (CHMP).
The panel backed approval of Betaferon (interferon beta-1b) for so-called emerging MS based on the results of the BENEFIT trial, which showed that giving Betaferon in the early stages of the disease reduced the risk of developing full-blown MS by 50% compared to placebo.
Schering said it expects approval of the new indication by the European Medicines Agency in the summer. The BENEFIT data have also been submitted to the US Food and Drug Administration (FDA), and the German drugmaker said it expects a verdict on the file before the end of the year.
Faced with increased competition in the MS sector from rival beta interferon products, as well as newer agents, Schering has been carrying out new clinical trials to expand the approved uses of Betaferon, still its top-selling drug with first-quarter sales of 232 million euros ($293m) and make its labelling more competitive.
Betaseron is already approved to treat the relapsing forms of multiple sclerosis and to reduce the frequency of clinical exacerbations, i.e. patients who have established MS. The new indication would make it possible for doctors to prescribe Betaseron to patients who have experienced a first clinical demyelinating event, in which the myelin sheath surrounding a nerve is lost.
And the benefit for Schering is that approval 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.
Meanwhile, in addition to BENEFIT, the company is carrying out the BEYOND trial, comparing the relative efficacy of a high-dose, 500mcg regimen of Betaferon with the regular 250mcg dose. The latter trial, which is now fully recruited, also includes a head-to-head comparison with a 20mg dose of Teva’s rival MS drug Copaxone (glatiramer acetate).