Merck Serono, a division of Germany's Merck, announced that the U.S. Food and Drug Administration (FDA) approved Rebif(R) Rebidose(R) (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).
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 trial showed that the majority of patients found the device easy to use.
Rebif RebiDose was designed with the objective to assist with ease of use and to offer patients an alternative delivery option. In the US, it will be available in a monthly pack in two different doses, 22 micrograms and 44 micrograms, and in a titration pack.
Rebif RebiDose was launched in Europe in 2010 and it 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.
"Over the past two decades, treatment of relapsing MS has advanced substantially, and Rebif has remained an established treatment option," said Belen Garijo, Head of Global Operations at Merck Serono. "We are committed to invest in valuable incremental innovations developed to bring additional value for the patient."