UCB Receives Positive EU CHMP Opinion for Cimzia AutoClicks Prefilled Pen

UCB announced that EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the use of Cimzia (certolizumab pegol) AutoClicks prefilled pen in all approved indications. The recommendation was based on validated data and risk benefit analysis for the pen.

In the EU, Cimzia is used in the treatment of arthritis. Studies have been conducted to evaluate if the AutoClicks pen can meet the needs of patients with autoimmune diseases such as rheumatoid arthritis.

The AutoClicks pen is based on core technology licensed from Bespak, a Consort subsidiary and manufacturer of drug-delivery devices for pharmaceutical partner companies. The autoinjector provides a button-free delivery system and a wide non-slip grip that keeps patient hand disability in mind. It has a large viewing window that shows the progress of the injection and it makes a clicking noise at the start of the injection and again when the injection is complete, giving patients confidence to know they have received their full dose of the drug.

In a usability study involving 76 moderate to severe rheumatoid arthritis patients, the AutoClicks pen was ranked as the most preferred device. Patients in this study also evaluated the autoinjector on a seven-point scale for its ease of use and their willingness to use it in the future. The AutoClicks Pen had the highest score on the scale compared with Enbrel (etanercept), Humira (adalimumab), and Simponi (golimumab) anti-TNF pens (p<0.05). Patients in this study had no prior experience using an anti-TNF pen.

Source: UCB