Policy & Regulation
US Food and Drug Administration Fast Track Designation for delgocitinib Cream for the Treatment of Adults with Moderate-to-Severe Chronic Hand Eczema
5 August 2020 - - Danish medical dermatology company LEO Pharma A/S's delgocitinib cream, an investigational topical pan-Janus kinase -inhibitor, has been granted Fast Track designation by the US Food and Drug Administration for the potential treatment of adults with moderate-to-severe chronic hand eczema, the company said.

There are currently no treatment options available in the US specifically developed and approved for the treatment of CHE.

CHE is defined as hand eczema that lasts for more than three months or relapsing twice or more within a year.

HE is the most common skin disorder of the hands that affects an estimated 5% of the general population8 with a one-year prevalence rate of approximately 10%.

It is an inflammatory, non-infectious skin disorder of the hands and wrists and can cause itching, blisters, swelling and pain so severe that it can impair the ability to work.

In a substantial number of patients, HE can develop into a chronic condition.

There is an unmet need for well-tolerated, effective and safe treatments for long-term control of CHE.

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.

The cream formulation of delgocitinib is not currently approved by any regulatory authorities.

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.

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'.

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.

In 2014, LEO Pharma A/S and Japan Tobacco Inc. entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialise 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.

LEO Pharma plans to submit the key results of the CHE Phase 2b study for publication later this year.

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 92m patients in 130 countries.
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