BMS receives positive CHMP opinion of new ORENCIA ClickJect Pre-Filled Pen for use in adult patients with moderate to severe active rheumatoid arthritis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion in the EU, approving Bristol-Myers Squibb’s ClickJect Pre-Filled Pen, a new autoinjector delivery device for ORENCIA (abatacept), for use in adult patients with moderate to severe active rheumatoid arthritis in combination with methotrexate after inadequate DMARD response.

Abatacept now offers a portfolio of three administration options, in the form of two subcutaneous (SC) self-injections; a pre-filled pen and the pre-filled syringe, as well as by intravenous infusion (IV).

ClickJect Pre-Filled Pen offers patients with rheumatoid arthritis greater flexibility in their treatment choice

“The new pre-filled pen offers patients with moderate to severe active rheumatoid arthritis a further administration option,” said Dr Andrew Östör, Director of the Rheumatology Clinical Research Unit, Addenbrooke’s Hospital, Cambridge. “This new delivery option provides patients the choice and flexibility they need in order to remain focused on their daily lives.”

ClickJect (abatacept) Pre-Filled Pen includes:

• A lightweight design  and a textured, non-slip surface to  aid grip
• A dark blue activation button that facilitates one-touch operation
• A large viewing window and a blue indicator that confirms the dose has been fully injected  
• Step-by-step instructions to simplify the injection process and help ensure reliable administration

“We are committed to providing people with rheumatoid arthritis a range of delivery options to help fit their individual lifestyles and treatment needs,” said Johanna Mercier, General Manager, BMS, UK and Ireland.  “ClickJect gives patients greater flexibility in their treatment choice with the goal of providing an optimal treatment experience.”

Abatacept is indicated for use in combination with methotrexate (MTX) to treat moderate to severe active RA in adults who have had an inadequate response to a disease-modifying anti-rheumatic drug (DMARD), including MTX or a tumour necrosis factor (TNF) antagonist (also known as an anti-TNF).