Rockland, MA and New York/PR Newswire/Jan 3
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) 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 U.S. in early 2013.
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. Those living with MS can learn more about Rebif Rebidose and other Rebif product offerings by talking with their physician, calling MS LifeLines toll-free at 1-877-447-3243 or visit www.Rebif.com [1]. For additional information about Rebif, please consult the Prescribing Information and Medication Guide.
SOURCE EMD Serono; Pfizer Inc.
