Adtralza is granted marketing authorisation from MHRA for a new pre-filled penSeptember 20, 2023
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Adtralza tralokinumab in a new pre-filled pen, following the European Commission (EU) decision on the 1st of September 2023. The pre-filled pen will be available in the UK for tralokinumab patients from early 2024.
Tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy. It is a high-affinity fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine, which has previously been available in a 150 mg in 1 ml pre-filled syringe.
The new 300 mg of tralokinumab in a 2 mL solution in the pre-filled pen will be a simplified method of administration for patients and prescribers, with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose given every other week. This is rather than four initial, and two maintenance doses with the 150 mg in 1mL pre-filled syringe, halving the number of injections required.2 The new pre-filled pen features a hidden needle and a press-down auto-injection with visual and audible feedback mechanisms to aid patients with administration.3
“We are pleased that this new simplified method of administration for tralokinumab will soon be available for appropriate atopic dermatitis patients in the UK as we strive to advance the standard of care and support for people living with skin conditions,” shared Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.