Ambient storage of interferon allowed

Published: 1-Jan-2003
Regulatory


The European Medicines Evaluation Agency (EMEA) has approved Schering's Betaferon (interferon β-1b) to be stored at room temperature (up to 25°C) for a period of up to three months.

For the first time patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) throughout Europe will not have to keep Betaferon refrigerated, which will allow greater convenience and flexibility. 'This approval gives patients more options for storage when travelling or pursuing activities outside their homes. This will improve their overall quality of life. In addition, improved patient compliance to Betaferon is expected,' said Dr Joachim-Friedrich Kapp, head of specialised therapeutics at Schering.

Two studies are currently being conducted with Betaferon: 'Benefit' and 'Beyond'. Benefit is a multicentre phase III study to investigate the efficacy and safety of interferon in persons with the first clinical symptoms indicative of MS. Beyond is a multinational phase III trial to assess a new high dose of interferon β-1b for subcutaneous injection in patients with relapsing-remitting MS. This study will be the largest MS trial, with more than 2,000 patients.

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