LEO Pharma Announces U.S. Food and Drug Administration Fast Track Designation for delgocitinib Cream for the Treatment of Adults With Moderate-to-severe Chronic Hand Eczema

The purpose of the Fast Track process is to get important potential new drugs to patients earlier¹

BALLERUP, Denmark & MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced that delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of adults with moderate-to-severe chronic hand eczema (CHE). There are currently no treatment options available in the U.S. specifically developed and approved for the treatment of CHE.^2,3,4

CHE is defined as hand eczema (HE) that lasts for more than three months or relapsing twice or more within a year.^5,6 HE is the most common skin disorder of the hands⁷ that affects an estimated 1 – 5% of the general population⁸ with a one-year prevalence rate of approximately 10%.⁹ It is an inflammatory, non-infectious skin disorder of the hands and wrists^5,10 and can cause itching, blisters, swelling and pain so severe that it can impair the ability to work.^5,7,11 In a substantial number of patients, HE can develop into a chronic condition.⁷ There is an unmet need for well-tolerated, effective and safe treatments for long-term control of CHE.^8,12,13,14

“Moderate-to-severe CHE can be a disabling skin disease that can disrupt the ability for people to work and be self-sufficient because their hands can feel so raw and painful,” said Kim Kjøller, M.D., Executive Vice President, Global Research and Development, LEO Pharma. “We are delighted that topical delgocitinib cream has been granted Fast Track designation and look forward to collaborating with the FDA during the development process as we aim to accelerate bringing this potential new treatment option to patients.”

Delgocitinib inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases.^15,16 The cream formulation of delgocitinib is not currently approved by any regulatory authorities.

About Fast Track

The FDA Fast Track process facilitates the development and expedites regulatory review of drugs to treat serious conditions and demonstrate the potential to address an unmet medical need.¹ According to the FDA, filling an unmet medical need is defined as ‘providing a therapy where none exists or providing a therapy which may be potentially better than available therapy’.¹

The frequency of communication during the FDA Fast Track process allows for questions to be addressed quickly, often leading to earlier drug approval and access by patients.¹

#ENDS#

About Delgocitinib

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

LEO Pharma recently completed a multi-center, randomized Phase 2b clinical trial with twice-daily topical delgocitinib cream for the treatment of adults with mild-to-severe CHE and a Phase 2b clinical trial with twice-daily topical delgocitinib cream for the treatment of adults with mild-to-severe atopic dermatitis (AD). LEO Pharma plans to submit the key results of the CHE Phase 2b study for publication later this year.

Find additional details at www.clinicaltrials.gov: NCT03683719 (CHE) and NCT03725722 (AD).

About LEO Pharma

The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. For more information about LEO Pharma, visit www.leo-pharma.com.

References

¹ U.S. Food and Drug Administration. Fast Track: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track (Accessed June 2020).

² Lee GR, et al. Dermatol Ther. 2019;e12840:1–12.

³ Shi V, et al. Clin. Invest. (Lond.) 2014;4:763–73.

⁴ Dibenedetti D, et al. J Clin Aesthet Dermatol. 2015;8:19–27.

⁵ Lynde C, et al. J Cutan Med Surg. 2010;14:267–84.

⁶ Diepgen TL, et al. J Dtsch Dermatol Ges. 2014;13:e1–22.

⁷ Bissonnette R, et al. JEADV. 2010;24;1–20.

⁸ Christoffers WA, et al. Cochrane Database Syst Rev. 2019;4:CD004055.

⁹ Thyssen et al. Contact Dermatitis. 2010;62:75-87.

¹⁰ Menné T, et al. Contact Dermatitis. 2011;65:3–12.

¹¹ Politiek K, et al. Contact Dermatitis. 2016;75:67–76.

¹² de León FJ, et al. Actas Dermosifiliogr. 2015;106:533–44.

¹³ Agarwal US, et al. Indian J Dermatol. 2014;59:213–24

¹⁴ Diepgen T. et al. Contact Derm. 2007;57:203-210.

¹⁵ Damsky W, and King BA. JAAD; 2017;76(4):736-744.

¹⁶ Virtanen AT, et al. BioDrugs. 2019;33:15–32.

Contacts

Media
Linda Mayer

Global Product Communications

+1 973 908 7924

limay@leo-pharma.com

Rhonda Sciarra
Global External Communications

+1 862 337 0675

RASUS@leo-pharma.com