European Medicines Agency Issues Positive Opinion for Cimzia AutoClicks Prefilled Pen

European Medicines Agency Issues Positive Opinion for Cimzia AutoClicks Prefilled Pen

UCB announced that its Cimzia (certolizumab pegol) AutoClicks Prefilled Pen has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The CHMP positive opinion designation concerning Cimzia is valid for conditions like rheumatoid arthritis (RA), psoriatic arthritis, Ankylosing spondylitis and Crohn’s disease. The opinion was based on a comparative usability study that enrolled moderate-to-severe RA patients, and also on how often patients gave the highest rankings to the AutoClicks Prefilled Pen as the most preferred treatment.

In total, 76 RA patients evaluated devices on a seven-point scale for its ease of use and their willingness to use it in the future. Researchers observed that the proprietary AutoClicks Prefilled Pen achieved the highest score on the scale compared to other devices, namely Enbrel (etanercept), Humira (adalimumab) and Simponi (golimumab) anti-TNF prefilled pens. No patients in the study had previous experience using an anti-TNF prefilled pen and all brand identification was removed from the devices.

The AutoClicks Prefilled pens have a non-slippery, button-free delivery system that keeps in mind patients’ hand disabilities. The device also has a large window for easy monitoring of the injection’s progress, and a clicking noise warns the patient every time an injection is initiated and completed, letting them know the full dosage of Cimzia has been administrated.

The Pen was developed by UCB in collaboration with OXO, a company that creates consumer household products for a broad range of users and using core technology developed and licensed by Bespeak, a consort medical company specializing in patient-centric medical devices.

“At UCB, we have made it a priority to develop a true understanding of the real world challenges for people living with severe rheumatologic conditions and to determine the best solutions. The availability of the AutoClicks Prefilled Pen will allow us to provide different administration options for patients treated with Cinzia,” Emmanuel Caeymaex, head of Immunology and executive vice president at UCB’s Immunology Patient Value Unit, said in a press release. “

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