European Medicines Agency recommends Adtralza 2 ml pen for patients with atopic dermatitis

Key takeaways:

• The recommendation is for the second injection option of Adtralza, a 2 ml pre-filled pen with a 300 mg dosage.
• Based on this positive opinion, a final decision from the European Commission is pending.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion of Adtralza for injection in a new single-dose 2 ml pre-filled pen, according to a press release.

Adtralza (tralokinumab, LEO Pharma), a high-affinity fully human monoclonal antibody, has previously been approved for a single dose injection of 150 mg from a 1 ml pre-filled syringe for the treatment of moderate to severe atopic dermatitis.

The new 2 ml pen will carry a 300 mg dose which will give patients the option to receive half the number of injections on a biweekly basis. However, the 1 ml syringe will continue to be available to patients that prefer it, according to the release.

The pre-filled pen was designed with a hidden needle and simple press-down auto-injection feature for ease of use. A visual and audible feedback mechanism in the pen will guide patients through the administration process.

“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,” Kreesten Meldgaard Madsen, chief development officer at LEO Pharma, said in the release.

The European Commission will review the committee’s positive opinion. If approved, the pen will be valid in all EU member states, Iceland, Norway and Liechtenstein. Meanwhile, the company is continuing to work on regulatory filings in other markets.