UCB, a global biopharmaceutical company focused on the discovery and development of innovative medicines, has announced that the European Medicines Agency’s (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 positive opinion was based on validated data and risk benefit analysis for the AutoClicks Pen.
“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 Cimzia. Patients have personal preferences for self-injection devices depending on their experience and individual needs, so having a pen and syringe will better support patients,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB.
Jon Glenn, Chief Executive Officer of Consort Medical, commented: “We are delighted that this sophisticated Autoinjector product, that relies on Bespak technology at its core, has received a positive opinion from the EMA enabling its European roll-out in the very near term. This is another important milestone for Bespak injectable franchise with the approval of our first product into the high value and high growth biologics market.”
UCB is committed to providing value to patients and meeting their unique needs. As part of this commitment, UCB continued its partnership with OXO, a company known for its smart, consumer friendly designs, to develop the AutoClicks Pen, based on core technology licensed from Bespak. The AutoClicks Pen 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 Cimzia.
Research was conducted to ensure that the AutoClicks Pen would meet the needs of patients living with autoimmune diseases like rheumatoid arthritis. In a comparative usability study with 76 moderate to severe rheumatoid arthritis (RA) patients simulating an injection using an injection pad, the RA patients gave the highest rankings to the AutoClicks Pen as the most preferred pen. Patients in the study also evaluated the AutoClicks Pen on a seven point scale for its ease of use and their willingness to use it in the future, giving it the highest score on the scale compared to Enbrel (etanercept), Humira (adalimumab) and Simponi (golimumab) anti-TNF pens (p?0.05).2 The patients in the study had no prior experience using an anti-TNF pen. All identification was removed from the pen devices and the instructions for use. Devices tested at time of study were approved for use in the UK.