FDA Approves Leo’s Single-Dose Autoinjector for Atopic Dermatitis

Leo Pharma has announced the approval of a new administration method for its atopic dermatitis treatment, Adbry (tralokinumab-ldrm), by the US Food and Drug Administration (FDA). This new option is a single-dose autoinjector, which is expected to provide an additional choice for patients.

Adbry targets the cytokine interleukin-13 (IL-13), which is known to drive inflammation associated with atopic dermatitis symptoms. The drug is intended for patients aged 12 and older with moderate-to-severe atopic dermatitis that is not adequately managed with topical prescription therapies. Originally approved in December 2021, Adbry has shown significant potential in treating this condition.

According to GlobalData, Adbry is poised to achieve global sales of $1.3 billion by 2030. In 2023 alone, the treatment generated $106 million in net global sales. This growth underscores the increasing demand and potential for effective treatments in the atopic dermatitis market.

The newly approved autoinjector delivers a 300 mg dose in 2 mL and will serve as an alternative to the existing 150 mg/1 mL pre-filled syringe. Both forms will continue to be available in the US. Leo Pharma plans to launch the new autoinjector in the coming months, providing more flexibility and options for patients.

Brian Hilberdink, EVP and President of Region North America at Leo Pharma, emphasized the company’s commitment to offering diverse treatment options. Shannon Schneider, Senior Medical Affairs Director at Leo Pharma, echoed this sentiment, noting that the extended approval marks a significant step forward in providing more choices for those living with atopic dermatitis.

Leo Pharma's focus on atopic dermatitis is part of a broader trend within the pharmaceutical industry. A report by GlobalData indicates that the atopic dermatitis market could be valued at $24.4 billion by 2030 across 61 geographical markets. A significant portion of this, 71.8%, is expected to come from the major markets of the US, France, Germany, Italy, Spain, the UK, and Japan.

Other pharmaceutical companies are also making significant strides in this field. Union Therapeutics, another Denmark-based company, recently announced positive results from its Phase IIb ADESOS study. This study evaluated orismilast as an oral treatment for moderate-to-severe atopic dermatitis. Union Therapeutics is planning to initiate a Phase III program and has approached the FDA with initial plans.

Additionally, Dermavant's nonsteroidal topical drug, VTAMA (tapinarof), has received FDA acceptance for its supplemental New Drug Application (sNDA). According to analysts at GlobalData, the atopic dermatitis market offers substantial opportunities, particularly for drugs targeting the aryl hydrocarbon receptor (AhR). These drugs have shown lower rates of adverse effects in clinical trials, making them a promising option for future treatments.

In conclusion, the approval of the Adbry autoinjector by the FDA marks a significant development in the treatment of atopic dermatitis. Leo Pharma's commitment to expanding treatment options, alongside the advancements made by other pharmaceutical companies, highlights the ongoing efforts to improve the quality of life for patients with atopic dermatitis. The future looks promising as the market continues to grow and new, effective treatments become available.