dm+d

39949911000001100

Refrigerated Storage

AdtralzaLeo Laboratories

Leo Laboratories
Adtralza
150mg solution for injection in pre-filled syringe

In the event of an inadvertent temperature excursion the following data may be used:
The product may be kept at room temperature up to 25°C for a maximum of 14 days within its shelf-life, without being refrigerated again during this period. After removal from the fridge, the product must be used within 14 days or discarded.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce to 14 days if exposed to the conditions above
See above
11 November 2021
London MI Service

New Medicines

Adtralza (EU/UK), Adbry (US) Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy

Information

Adtralza (EU/UK), Adbry (US)
New molecular entity
Leo Pharma
Leo Pharma

Development and Regulatory status

Launched
Launched
Launched
August 2021
Feb 22Adbry is available in the US. Adtralza has been available in Germany since Jul 21 [19,20].
Dec 21Approved in the US for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older; launch is planned for February 22 [18].
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 (EU/UK), Adbry (US) Moderate to severe atopic dermatitis in adolescents (12-17 years)

Information

Adtralza (EU/UK), Adbry (US)
Licence extension / variation
Leo Pharma
Leo Pharma

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Jan 22EMA CHMP starts reviewing application to extend the indication for Adtralza to include treatment of adolescent patients (12-17 years) based on PIII ECZTRA 6 study [6].

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

Trial or other data

Oct 21PIII ECZTRA trial meets primary endpoints. At week 16, clear or almost-clear skin as measured by IGA was achieved by 21.4% on 150mg (p<0.001) and 17.5% on 300mg (p=0.002) vs. 4.3% with placebo. A 75% or greater disease improvement from baseline as measured by EASI was achieved by 28.6% (p<0.001) on 150mg and 27.8% (p=0.001) on 300mg vs. 6.4% with placebo. Tralokinumab was well tolerated [5].
Dec 20Primary completion date for PIII ECZTRA 6 trial was March 2020 [4]; results are awaited.
Nov 19The estimated primary completion date for PIII ECZTRA 6 is April 2020 [3].
Jul 19 PIII ECZTRA 6 study is recruiting [2].
Jun 18PIII ECZTRA 6 (ECZema TRAlokinumab Trial no. 6) study to evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD starts (NCT03526861). 294 patients will be recruited in the US, Australia, Belgium, Canada, France, Germany, Japan, Netherlands, Poland and UK. Collection of primary outcome data (Investigator´s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16. and at least 75% reduction in Eczema Area and Severity Index (EASI75) at Week 16) is due to complete collection in Jul 19 [2].

Evidence based evaluations