Schering AG, Germany announced that the European Commission has approved an expansion of the storage schedule for the multiple sclerosis drug Betaferon (interferon beta-1b) for a period of up to 24 months at room temperature (up to 25ºC / 77°F).
Patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) in the 25 EU countries including Germany, France, Italy and the United Kingdom, will now benefit from the added convenience of an even longer period of refrigerator-free storage of their Betaferon therapy, company informed in a release.
Because the formulation of Betaferon remains unchanged, all Betaferon medication already currently on the market may be stored for up to two years.
"This approval makes Betaferon an even more convenient drug for patients," said Dr. Joachim-Friedrich Kapp, Head of Specialized Therapeutics, a member of the Schering AG, Germany Group. "This new product characteristic shows our commitment to providing MS patients with the best care options," he added.
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June. In the US and Japan, approval to store Betaferon for 24 months at room temperature was granted in 2002 and 2000 respectively.
Experience gained with patients in the United States and Japan not only demonstrates an improvement in the overall quality of life of MS patients, but the expanded storage duration also may increase patient compliance.
Betaferon, which is marketed in the US as Betaseron by Berlex Laboratories, a US affiliate of Schering AG, is one of the leading MS therapies worldwide.
Multiple Sclerosis (MS) is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect over 1,000,000 people worldwide, and is the major acquired neurologic disease in young adults.
Clinical studies have shown that high-dose treatment with interferons is more effective than low-dose therapies. Betaferon reduces the frequency of MS episodes by one third and reduces the intensity of medium to severe episodes by up to 50 per cent, the release says.