Rebif Rebidose approved by FDA for self administration to treat Multiple Sclerosis

The FDA has on 3 January 2013. approved Rebif Rebidose (interferon beta-1a), a single-use auto-injector for the self-administration of Rebif, a disease-modifying drug used to treat relapsing forms of Multiple Sclerosis.

Rebif Rebidose was evaluated in a 12-week Phase IIIb multicenter, open-label, single-arm study for the self-administration of Rebif with respect to ease of use, patient satisfaction and acceptability, and functional reliability. In the trial, patients with relapsing MS, who were receiving Rebif 44 microgram three times weekly for more than 12 weeks, continued MS therapy using Rebif Rebidose for 12 weeks. The results of the Rebif Rebidose user trial showed that the majority of patients found the device easy to use.

With this approval, all three delivery options of Rebif (prefilled syringes, Rebiject II and Rebif Rebidose) will be available in the U.S. to provide a range of options to meet the needs of patients treating their relapsing forms of MS with Rebif.