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FDA Approves Rebif Rebidose (Interferon Beta-1a) Auto-Injector for MS
Decision based on ease-of-use data (Jan. 3)
The FDA has approved Rebif Rebidose (interferon beta-1a, EMD Serono/Pfizer), a single-use auto-injector for the self-administration of Rebif, a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS).
The device was evaluated in a 12-week phase IIIb open-label study for the self-administration of Rebif with respect to ease of use, patient satisfaction and acceptability, and functional reliability. In the trial, 109 patients with relapsing MS, who had received Rebif 44 mcg three times weekly for more than 12 weeks, continued MS therapy using Rebif Rebidose for 12 weeks. The study results showed that most of the patients found the device easy to use.
Rebif Rebidose will be available in the U.S. in early 2013.
Rebif (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and to delay the occurrence of some of the physical disability that commonly occurs in patients with MS. Rebif is not approved for the treatment of chronic progressive MS. The drug may cause serious side effects, including depression, liver problems, risk to pregnancy, and allergic reactions.
Source: EMD Serono/Pfizer; January 3, 2013.