The US Food and Drug Administration (FDA) has 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 (MS).  

"We are pleased to announce the FDA has approved Rebif Rebidose which provides people living with relapsing MS another option to meet their injection needs," said James Hoyes , president of EMD Serono, Inc. "The introduction of Rebif Rebidose underscores our commitment to the MS community and to our investment in the development of delivery devices to assist with ease of use and support those living with MS."

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.

"Over the past two decades, treatment of relapsing MS has advanced and interferons such as Rebif have remained an established treatment option," said Liz Barrett , president, North America, Pfizer Specialty Care. "Rebif has a well-established safety profile with 18 years of clinical trial and patient experience. We are proud to offer another delivery option for Rebif with the approval of Rebif Rebidose in the United States."

Rebif Rebidose (interferon beta-1a) was designed with the objective to assist with ease of use and to offer patients an alternative delivery option. Rebif Rebidose will be available in a monthly pack in two different doses, 22 micrograms and 44 micrograms, and in a titration pack.

Rebif Rebidose will be available in the US in early 2013.  With this approval, all three delivery options of Rebif (prefilled syringes, Rebiject II and Rebif Rebidose) will be available in the US to provide a range of options to meet the needs of patients treating their relapsing forms of MS with Rebif.  

The user trial was a 12-week, phase IIIb, multicenter, open-label, single-arm study to evaluate Rebif Rebidose, for the self-administration of Rebif with respect to ease of use, patient satisfaction and acceptability, and functional reliability. 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.

A total of 109 patients were enrolled in the study. Patients were between 18 and 65 years old with relapsing MS (McDonald criteria) and had received Rebif, 44 microgram three times weekly, consistently for 12 weeks or more prior to screening. Patients completed a user trial questionnaire at baseline and weeks 6 and 12.

The primary endpoint was the proportion of patients rating Rebif Rebidose as "easy to use" or "very easy to use" at week 12. Safety evaluation included the incidence of serious adverse events (AEs).

Rebif is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. Rebif is not approved for treatment of chronic progressive MS. Rebif is available in 22 mcg and 44 mcg prefilled, preassembled syringes and a titration pack.

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives.