FDA Approves Interferon Autoinjector for MS

Susan Jeffrey

January 03, 2013

The US Food and Drug Administration has approved a single-use autoinjector (Rebidose, EMD Serono Inc./Pfizer Inc) for self-injection of interferon beta-1a (Rebif) in the treatment of relapsing forms of multiple sclerosis (MS), the companies announced today.

Approval was based on a 12-week phase 3b 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 μg, 3 times weekly, for 12 weeks or more before screening. Patients then completed a user trial questionnaire at weeks 6 and 12.

The primary endpoint was the proportion of patients rating the autoinjector 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.

The autoinjector will be available early in 2013, in a monthly pack in 2 different doses, 22 and 44 μg, and in a titration pack.

"With this approval, all 3 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," the statement notes.

Users should demonstrate competency in all aspects of the injection before independent use, it notes. Patients with severe neurologic deficits should not self-administer injections without assistance from a trained caregiver.

The prescribing information and medication guide for Rebif are available online.

The FDA approved another autoinjector option (Avonex Pen, Biogen Idec) for another interferon beta-1a product (Avonex) in March 2012.