By Ursula Zerilli | [email protected]
on January 14, 2013 at 4:30 PM
KALAMAZOO, MI – The U.S. Food and Drug Administration approved Pfizer Inc. and EMD Serono, Inc.’s single-use, auto-injector treatment device for multiple sclerosis patients called Rebif Rebidose on Jan. 3.
“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.
With this approval, all three delivery options of Rebif, which comes in prefilled syringes, Rebiject II and now Rebif Rebidose, will be available in the U.S. for patients treating their relapsing forms of MS.
The pharmaceutical companies say the auto-injector device is designed to assist with ease of use as an alternative delivery option. Rebif Rebidose will be available in a monthly pack in doses of 22 micrograms and 44 micrograms and in a titration pack.
The treatment device was evaluated in a 12-week, single-arm study for the self-administration of Rebif with respect to ease of use in 109 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 will be available in the U.S. in early 2013. Pharmaceutical giant Pfizer Inc. is also one of Kalamazoo’s largest employers.
Contact Ursula Zerilli at [email protected] or 269-254-5295. .
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