EMD Serono, a subsidiary of Merck, and Pfizer have announced the FDA approval of Rebif Rebidose (interferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS).
Rebif Rebidose was designed as single-use auto-injector for the self-administration of Rebif, a disease-modifying drug.
The company anticipates making the product available in a monthly pack in 22 micrograms and 44 micrograms, and in a titration pack in the US in early 2013.
EMD Serono president James Hoyes said, "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."
A Phase IIIb multicenter study of Rebif Rebidose conducted in patients with relapsing MS demonstrated that the majority of patients experienced the easy use of the device.
Pfizer Specialty Care North America president Liz Barrett said, "Rebif has a well-established safety profile with 18 years of clinical trial and patient experience."
