Merck received FDA clearance for the Rebif Rebidose interferon beta-1a injector for patients with relapsing forms of multiple sclerosis (MS). With this approval, in addition to prefilled syringes and the Rebiject II injector, people with MS in the United States have access to all three forms of Rebif.
Merck Serono, the U.S. division of the company promises to make the Rebidose injector available early this year.
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. Rebif RebiDose was designed with the objective to assist with ease of use and to offer patients an alternative delivery option. In the US, 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 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.
Press release: Merck Serono Announces FDA Approval of Rebif® Rebidose® (interferon beta-1a)
Product page: RebiDose…
