CHMP Recommends Approval of Leo's Adtralza Pre-filled 2 mL Pen

The CHMP’s positive opinion will be reviewed by the EC and, pending the final decision, authorization of the pre-filled pen will be valid in all EU member states, Iceland, Norway, and Liechtenstein.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending the approval of Adtralza (tralokinumab) in a (300 mg) 2 mL pre-filled pen. 

With the pre-filled syringe, a single 300-mg dose given every other week rather than two 150-mg doses. It has previously been available in a 1 ml pre-filled syringe. This administration option will continue to be available in markets where Adtralza is already launched. 

Adtralza, a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, is approved for the treatment of adult and adolescent patients with moderate-to-severe AD in the European Union, Canada, Great Britain, and the United Arab Emirates, and is approved for adults with moderate-to-severe AD in Switzerland, Saudi Arabia, and Japan. In the U.S., marketed under the tradename Adbry. Adtralza, a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine.

“Not only will the Adtralza 2 mL pre-filled pen be more convenient by reducing the number of injections required, but it also eases administration by simplifying the injection process for patients,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma, in a news release. “This milestone brings us a step closer to providing the best possible support to patients, caregivers and prescribers in the management of moderate-to-severe atopic dermatitis.” 

The pre-filled pen features a hidden needle and a press-down auto-injection with visual and audible feedback mechanisms to aid patients with administration. 

The CHMP’s positive opinion will be reviewed by the European Commission (EC) and, pending the final decision, authorization of the pre-filled pen will be valid in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway.