Rebif Rebidose (interferon beta-1a), a single-use auto-injector for the self-administration of Rebif®, has been approved by the U.S. Food and Drug administration for the treatment of relapsing forms of MS, according to EMD Serono.
A statement issued by the company said that it anticipates making the product available in a monthly pack in 22 micrograms and 44 micrograms, and in a titration pack. It is expected to be available in theUSin early 2013.
Approval was based on a 12-week phase IIIb multicenter, open-label, single-group study looking at ease of use, patient satisfaction and acceptability, and functional reliability, according to the statement. The 109 participants, aged 18 to 65 years, had relapsing MS meeting McDonald criteria and had already been treated consistently with 44 micrograms, three times weekly, for 12 weeks or more before screening. Patients then completed a user trial questionnaire at weeks six and 12.
The primary endpoint was the proportion of participants rating the auto-injector as "easy to use" or "very easy to use" at week 12. Safety evaluation included the incidence of serious adverse events. Results showed that "the majority of patients found the device easy to use," the statement notes.
With this approval, there are now three delivery options for Rebif: prefilled syringes, Rebiject II, and Rebif Rebidose. Users should demonstrate competency in all aspects of the injection before independent use, and people with severe neurologic deficits should not self-administer injections without assistance from a trained caregiver.