Delgocitinib

Annual Report 2023: LEO Pharma Delivers 10% Revenue Growth and Returns to Positive EBITDA

Retrieved on: 
Thursday, February 29, 2024

LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and an EBITDA uplift of DKK 2.1 billion, corresponding to a 20%-points margin improvement.

Key Points: 
  • LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and an EBITDA uplift of DKK 2.1 billion, corresponding to a 20%-points margin improvement.
  • LEO Pharma exceeded our profitability guidance and hit the upper range of our revenue growth guidance provided in March 2023.
  • LEO Pharma delivered 11.4 billion in revenue, corresponding to 7% revenue growth in 2023.
  • LEO Pharma exceeded our profitability guidance and hit the upper range of our revenue growth guidance provided in March 2023.

LEO Pharma Announces Positive Phase 3 Head-to-head Data Results from DELTA FORCE Trial Comparing Delgocitinib Cream With Alitretinoin Capsules in Adults With Severe Chronic Hand Eczema (CHE)

Retrieved on: 
Wednesday, January 24, 2024

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the DELTA FORCE trial.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced positive results from the DELTA FORCE trial.
  • Delgocitinib cream achieved the primary outcome measure of the trial by demonstrating a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules.
  • Furthermore, patients receiving delgocitinib cream had a lower number of treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules.
  • Detailed results from DELTA FORCE are planned to be submitted for scientific presentation and publication at a later date.

EMA Accepts LEO Pharma’s Marketing Authorization Application (MAA) for Delgocitinib Cream in Chronic Hand Eczema (CHE)

Retrieved on: 
Friday, August 18, 2023

LEO Pharma A/S announces today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE).

Key Points: 
  • LEO Pharma A/S announces today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE).
  • “We are delighted that delgocitinib cream has entered this first stage of the European regulatory process.
  • “Chronic hand eczema negatively impacts patients’ quality of life, psychological well-being, physical functioning, and ability to work.
  • LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe CHE in adults.

LEO Pharma Adds Internationally Recognized Dermatologist to Global Leadership Team

Retrieved on: 
Tuesday, March 14, 2023

To lead Research and Early Development, LEO Pharma has appointed Dr. Jacob Pontoppidan Thyssen as new Executive Vice President and Chief Scientific Officer.

Key Points: 
  • To lead Research and Early Development, LEO Pharma has appointed Dr. Jacob Pontoppidan Thyssen as new Executive Vice President and Chief Scientific Officer.
  • Jacob is an internationally recognized dermatologist and key opinion leader who will add his clinical experience and strong understanding of patients’ needs into LEO Pharma's drug development.
  • To support these two critical pillars, LEO Pharma today announced a split of its Research and Development organization into two distinct areas, both represented in the Global Leadership Team (GLT).
  • I am delighted to welcome Jacob to LEO Pharma and the Global Leadership Team and am confident that his experience will help spearhead our innovative portfolio.

LEO Pharma Announces Positive Phase 3 Topline Results From DELTA 2 Trial With Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (CHE), Confirming the Positive Results of the Recent DELTA 1 Trial

Retrieved on: 
Friday, February 10, 2023

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of the DELTA 2 trial.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of the DELTA 2 trial.
  • DELTA 2 is the second of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).
  • Further analyses of the data set will be conducted to determine the full potential of delgocitinib cream in the treatment of adults with moderate to severe CHE.
  • Detailed results from DELTA 2 are planned to be submitted for scientific presentation and publication at a later date.

LEO Pharma initiates the first Phase 3 clinical trial with delgocitinib cream in adult patients with moderate-to-severe chronic hand eczema (CHE)

Retrieved on: 
Tuesday, May 18, 2021

LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries.

Key Points: 
  • LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries.
  • The topical pan-JAK inhibitor delgocitinib cream demonstrates dose response in a 16-week phase 2b trial in chronic hand eczema.
  • A phase 2b trial evaluating the efficacy of delgocitinib cream for the treatment of chronic hand eczema (CHE) using and validating the Hand Eczema Severity Index (HECSI).
  • E-poster presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 23-25 April 2021.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210517005624/en/\n'

LEO Pharma announces positive results of Phase 2b dose-finding study with delgocitinib cream in adult patients with mild-to-severe chronic hand eczema (CHE)

Retrieved on: 
Thursday, October 29, 2020

The results of this trial showed that delgocitinib cream may have the potential to become a new treatment option for adult patients suffering from mild-to-severe CHE.

Key Points: 
  • The results of this trial showed that delgocitinib cream may have the potential to become a new treatment option for adult patients suffering from mild-to-severe CHE.
  • Earlier this year, delgocitinib cream received Fast Track designation for the treatment of moderate-to-severe CHE from the U.S. Food and Drug Administration.
  • LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.
  • The topical pan-JAK inhibitor delgocitinib cream demonstrates dose response in a 16-week phase 2b trial in chronic hand eczema.

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

Retrieved on: 
Tuesday, August 4, 2020

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).

Key Points: 
  • 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).
  • 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.
  • LEO Pharma plans to submit the key results of the CHE Phase 2b study for publication later this year.
  • LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.