MHRA grants authorisation for LEO Pharma's Adtralza 2 mL pen solution

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution developed by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients in the UK from early 2024.

Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available in a 150 mg in 1 mL pre-filled syringe.

According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week.

"We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

The 300 mg in 2 mL pre-filled pen simplifies the dosing regimen, requiring fewer injections compared to the 150 mg in 1 mL pre-filled syringe. This pen incorporates a concealed needle and employs a press-down auto-injection system with visual and audible feedback mechanisms, aiding patients in administration, the statement added.

In June, Former Prime Minister Theresa May inaugurated LEO Pharma's new UK and Ireland offices in Maidenhead, Berkshire. This site at Foundation Park now serves as the operational headquarters for the region. With over 60 years of dermatology product manufacturing in the UK and Ireland, LEO Pharma remains committed to the development of the Maidenhead area, its base for the past decade.