dm+d

Unassigned

New Medicines

Adtralza Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy

Information

Adtralza
New molecular entity
Leo Pharma
Leo Pharma

Development and Regulatory status

Launched
Approved (Licensed)
Pre-registration (Filed)
August 2021
Aug 21 Adtralza 150mg solution for injection in prefilled syringe available in the UK. Price for 4 PFS =£1070.00 [17].
Jun 21Approved in EU for moderate-to-severe atopic dermatitis in adults [15].
Jun 21Licensed in UK for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. [16].
Apr 21Recommended for EU approval by CHMP - the full indication is " Adtralza is indicated for treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy." Adtralza will be available as 150 mg solution for injection [14].
Mar 21Is also pre-registration in the US [13].
May 20Currently pre-registration in EU [11].
Feb 20Following announcement that tralokinumab met all primary & secondary outcomes in its pivotal studies, LEO Pharma is prepare filing in the US, Europe and Japan, for its first global biologics launch [10].
Jul 16AstraZeneca grants Leo Pharma an exclusive, global licence to tralokinumab in skin diseases. AstraZeneca will manufacture and supply tralokinumab to LEO Pharma, & will retain all rights to tralokinumab in respiratory disease and any other indications outside of dermatology [4].

Category

Anti-IL-13 MAb
Atopic eczema is common and the prevalence is increasing. It is seen in 20% of children in developed countries and in developing countries the prevalence is heading towards this figure. In adults, population studies report an overall prevalence of 2-18% [3].
Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy
Subcutaneous

Further information

Yes

Trial or other data

Oct 20PIII ECZTRA 1 and 2 are published; tralokinumab monotherapy was well tolerated, and superior to placebo at 16 weeks for IGA score of 0/1 and EASI 75 response in both studies (15.8% vs 7.1% & 25.0% vs 12.7% respectively for ECZTRA 1 [n=802]; 2.2% vs 10.9% & 33.2% vs 11.4% for ECZTRA 2 [n=794] [all p<0.002]) [12].
Dec 19Three pivotal PIII studies (ECZTRA 1-3, all 16-week trials) met all primary and secondary endpoints for the treatment of moderate-to-severe atopic dermatitis (AD) in adults [9].
Oct 19PIII ECZTRA 1 trial has completed; results are awaited [8].
Sep 19PIII ECZTRA 3 trial has completed; results are awaited [8].
Aug 19PIII ECZTRA 2 trial has completed; results are awaited [8].
Nov 18PIII ECZTRA 7 trial to demonstrate that tralokinumab in combination with topical corticosteroids is superior to placebo in combination with topical corticosteroids in treating severe atopic dermatitis in participants who are not adequately controlled with or have contraindications to oral cyclosporine A has started (NCT03761537). The double-blind, randomised trial is enrolling approximately 333 patients in France, Belgium, Spain and Germany and will expand to Poland and the UK [7].
Apr 18PIII ECZTRA 1 and 2 trials have completed recruitment; primary outcome data collection expected to complete in Feb 20 for ECZTRA 1, and in Nov 19 for ECZTRA 2 [5].
Feb 18PIII ECZTRA 3 clinical trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy, starts. The primary endpoint is to assess subjects with Investigator´s Global Assessment (IGA) score of 0 (clear) or 1(almost clear)at week 16 and subjects achieving at least 75% reduction in Eczema Area and Severity Index (EASI) [6].
Jun 17PIII ECZTRA 2 trial to evaluate the efficacy and safety of tralokinumab monotherapy, in subjects with moderate to severe atopic dermatitis, who are candidates for systemic therapy starts (NCT03160885). Evaluation of the Investigator´s Global Assessment (IGA) score and reduction in Eczema Area and Severity Index are the defined primary endpoints of the trial. The randomised, double-blind, placebo-controlled trial intends to enrol approximately 780 patients in the US and the enrolment will extend to Australia. Collection of primary outcome data is due Nov 19 [2].
May 17PIII ECZTRA 1 clinical trial to evaluate the efficacy and safety of tralokinumab monotherapy, in subjects with moderate to severe atopic dermatitis, who are candidates for systemic therapy starts (NCT03131648). Evaluation of the Investigator´s Global Assessment (IGA) score and reduction in Eczema Area and Severity Index are the defined primary endpoints of the trial. The randomised, double-blind, placebo-controlled trial intends to enrol approximately 780 patients. Enrolment is underway in the US, Spain and will extend to France, Germany [2].

Evidence based evaluations

Adtralza Moderate to severe atopic dermatitis in adolescents (12-17 years)

Information

Adtralza
Licence extension / variation
Leo Pharma
Leo Pharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Anti-IL-13 MAb
Atopic eczema is common and the prevalence is increasing. It is seen in 20% of children in developed countries and in developing countries the prevalence is heading towards this figure. In adults, population studies report an overall prevalence of 2-18% [1].
Moderate to severe atopic dermatitis in adolescents (12-17 years)
Subcutaneous

Further information

Yes

Evidence based evaluations