Pipeline systemic atopic dermatitis treatments for children offer hope for severe cases, says GlobalData

28 Sep, 2022 Pipeline systemic atopic dermatitis treatments for children offer hope for severe cases, says GlobalData

Posted in Pharma

Great strides will be made in the treatment of atopic dermatitis (AD) in children in the next decade, according to GlobalData, which notes the presence of several systemic treatments in the pipeline. The leading data and analytics company highlights that this will bring hope to children with severe AD, which is a very underserved patient population.

AD is an inflammatory skin disease affecting up to one in five* children that negatively impacts quality of life due to constant itching and sleep deprivation. While AD in children is currently treated with topical medicines on specific areas of skin, this is not ideal for severe cases wherein a systemic treatment-drugs that work throughout the whole body-would be better suited. However, the historically available systemic treatments often come with serious side effects, and their use is extremely limited in children.

Sanofi's Dupixent offers systemic approach to children with severe AD

According to GlobalData's Atopic Dermatitis Market Size and Trend Report, 2021-2030', the AD pipeline currently contains several systemic treatments that are intended to be used in children, either initially or after expansion. Developers include Eli Lilly, AbbVie, LEO Pharma, and Galderma. These will be competing with the recently approved Dupixent, which is a gold standard in the treatment of AD in adults.

Ramla Salad, Pharma Analyst at GlobalData, comments: "The announcement in June 2022 that the FDA approved Dupixent in children with moderate-to-severe AD is a huge step forward, and will offer Sanofi and Regeneron a steep market advantage well ahead of its competitors, which currently have products in Phase I to Phase III development. Furthermore, Dupixent is widely known as the gold-standard therapy for the treatment of moderate to severe AD, so parents and caretakers may be less reluctant to initiate treatment as the safety profile of Dupixent is well established and favorable for patients in both the short and the long term.

"Regardless, the collective development provides hope for young patients-especially those who have more severe AD that are in need of an effective disease-modifying agent."

In addition to Dupixent, the other systemic agents being investigated for use in pediatric patients under 12 years include Eli Lilly's Olumiant, AbbVie's Rinvoq, LEO Pharma's Adtralza/Adbry, and Galderma's nemolizumab. Salad outlines a these systemic treatments below:

Eli Lily's Olumiant trial for AD in children ends 2026 but lacks US approvals

Eli Lilly's oral JAK1 inhibitor Olumiant is already approved for use for AD in adults across the 5EU** and Japan, but is not yet approved for the US market. Its ability to treat children aged 2-17 years is currently being investigated in Phase III trial BREEZE-AD-PEDS (NCT03952559), which is expected to complete in May 2026.

Salad continues: "Olumiant is currently the only oral JAK not approved in the US for the treatment of moderare to severe AD and this will impact its market share as patients become more used to using other JAK inhibitors. This delay will in turn impact Lilly's competitiveness in the US however not so much in the EU as was approved much earlier (2020) in that geography."

AbbVie's Rinvoq has real-world evidence but only in Phase I

AbbVie's Rinvoq is being investigated in a Phase I trial (NCT03646604) for use in children aged 2-12 years. This trial is not expected to read out until September 2024, and its primary endpoints are studying safety and pharmacokinetics.

Salad adds: "On top of this Phase I study, AbbVie will need to register a Phase III pivotal trial assessing efficacy in younger patients to support a regulatory approval. However, Rinvoq has already been approved for use in adults and adolescents in the US and the EU, so the company has some real-world evidence to support its clinical development program".

LEO Pharma's Adtralza/Adbry looks to expand to adolescents and children

LEO Pharma's Adtralza/Adbry is being investigated in pediatric patients aged 2-11 years through the Phase II trial, TRAPEDS 1 (NCT05388760). This trial is expected to read out in August 2024, and, similarly to Rinvoq, it is also approved for use in adults in both the US and the EU.

Salad notes: "LEO is hoping to expand into adolescent patients following a discussion at the Committee for Medicinal Products for Human Use (CHMP) agenda meeting on March 21-24, 2022; this discussion was based on safety and efficacy data from the Phase III trial, ECZTRA 6 (NCT03526861)."

Galderma's nemolizumab on backfoot due to limited adult approvals

Galderma's nemolizumab is being investigated in a Phase II trial (NCT04921345) for patients aged 2-12 years. The trial is expected to read out in January 2025.

Salad concludes: "Nemolizumab is only currently approved for use in adults in Japan, under the brand name Mitchga, so it falls behind its competitors in overall global access."

* 10-20% of children in developed countries

** 5EU = France, Germany, Italy, Spain and the UK