Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has introduced Rebif (interferon beta-1a) in the UK to treat people who have experienced clinically isolated syndrome (CIS), an early sign of multiple sclerosis (MS).
Rebif, a disease-modifying drug, is available in a 22mg and 44mg ready-to-use prefilled syringe and a titration pack (8.8mg), and is also now available in two multidose cartridges (132mg – three doses of 44mg, and 66mg – three doses of 22mg) for use with the RebiSmart electronic auto-injection device.
The initiative follows the recent positive opinion adopted by the Committee of Medicinal Products (CHMP), the scientific committee of the European Medicines Agency (EMA). Rebif 44mg is approved for use three times a week following a single demyelinating event, in people who are at high risk of converting to MS.
The extention of the indication is supported by a Phase III, randomised, double-blind, placebo-controlled, multicentre Reflex study of the 44mg formulation of Rebif in patients at high risk of converting to MS.
Royal Victoria Infirmary Newcastle, UK professor David Bates said the licensing of Rebif, an established disease modifying therapy (DMT), for people with multiple sclerosis is an additional early treatment for the patients. Rebif is already indicated to treat relapsing forms of MS and has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity. The company said Rebif should be used with caution in patients with a history of depression, liver disease and seizures.
Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. The company continues to invest in discovering and developing treatments in this area, including active life cycle management initiatives targeting numerous aspects of the company’s foundation therapy Rebif (formulation, indication, delivery devices).