ADTRALZA® (TRALOKINUMAB)


Associated tags: FDA, Atopic dermatitis, Food, Vaccine, Health, Science, Dermatology, Leo Pharma, Patient, Research, LEO, Pharmaceutical, Pharmaceutical industry, Tralokinumab, EC, AD, European Commission, DKK, Dermatitis, Safety, Royal commission, Disease

Locations: CANADA, UNITED STATES, UNITED ARAB EMIRATES, AD

Japan Ministry of Health, Labor and Welfare Approves Manufacturing and Marketing of Adtralza® (tralokinumab) in Japan for Adults with Atopic Dermatitis

Retrieved on: 
Friday, December 23, 2022
Biotechnology, Pharmaceutical, Health, Dermatology, Leo Pharma, Patient, Investment, MHLW, LEO, National Association Medical Staff Services, Atopic dermatitis, Marketing, Pharmaceutical industry, Health, Tralokinumab

LEO Pharma A/S, a global leader in medical dermatology, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza® (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacturing and marketing of Adtralza® (tralokinumab) subcutaneous injection (S.C.) for adults with atopic dermatitis, which has inadequately responded to conventional therapies.
  • “Today’s approval is a significant advancement for those patients in Japan who continue to suffer from the often-debilitating symptoms of atopic dermatitis and are in need of a new treatment option to manage their chronic condition,” said Kook Hyun Son, General Manager of LEO Pharma K.K.
  • “The Japan approval is a demonstration of our strategy to expand the availability of Adtralza to millions of patients around the world who are faced with the daily challenges of living with chronic and often debilitating symptoms of atopic dermatitis,” said Becki Morison, executive vice president of global strategy and international operations, LEO Pharma A/S.
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LEO Pharma Announces European Commission Approval of Adtralza® (tralokinumab) for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents

Retrieved on: 
Thursday, October 20, 2022
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Atopic dermatitis, Disease, Royal commission, Population, Review, Science, GPER, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Poster, Sleep, IGA, EASI, Research, MPH, University, Food, Adolescence, Department, Ludwig Maximilian University of Munich, Â, Leo Pharma, United Arab Emirates, Adult, Ageing, Safety, LEO, Dermatitis, DKK, EC, AD, European, European Commission, Week, Itch, FDA, Pharmaceutical industry, Vaccine, Tralokinumab, Dermatology

The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.

Key Points: 
  • The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.
  • The European Commissions approval of Adtralza for use in adolescent patients is a demonstration of our relentless commitment to bringing new treatment options to those living with atopic dermatitis, said Christophe Bourdon, Chief Executive Officer, LEO Pharma A/S.
  • LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world.
  • Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial.

LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Monday, September 19, 2022
Managed Care, General Health, Pharmaceutical, Health, Adult, EASI, Safety, SCORAD, FDA, AD, Food, Leo Pharma, European Medicines Agency, Week, European Commission, Population, Adolescence, Atopic dermatitis, IGA, Patient, Committee for Medicinal Products for Human Use, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Itch, Dermatology, Eczema Area and Severity Index, European Directive on Traditional Herbal Medicinal Products, United Arab Emirates, Science, CHMP, EC, Poster, Research, Ageing, DKK, NRS, Royal commission, Committee, Union, LEO, EMA, Disease, Dermatitis, Vaccine, Pharmaceutical industry, Tralokinumab, EU

There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis.

Key Points: 
  • There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis.
  • LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world.
  • Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial.
  • Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no.

LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Friday, September 16, 2022
Biotechnology, Pharmaceutical, Teens, General Health, Health, Consumer, Clinical Trials, Other Health, Adult, EASI, Safety, SCORAD, FDA, AD, Food, Leo Pharma, European Medicines Agency, Week, European Commission, Population, Adolescence, Atopic dermatitis, IGA, Patient, Committee for Medicinal Products for Human Use, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Itch, Dermatology, Eczema Area and Severity Index, European Directive on Traditional Herbal Medicinal Products, United Arab Emirates, Science, CHMP, EC, Poster, Research, Ageing, DKK, NRS, Royal commission, Committee, Union, LEO, EMA, Disease, Dermatitis, Vaccine, Pharmaceutical industry, Tralokinumab, EU

There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis.

Key Points: 
  • There are limited treatment options for adolescents in the EU living with moderate-to-severe atopic dermatitis.
  • LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world.
  • Paller A. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial.
  • Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no.

NICE Publishes Final Appraisal Document Recommending the Use of Adtralza® (tralokinumab) for Adult Patients With Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Wednesday, June 29, 2022
Health, Science, Pharmaceutical, Research, Clinical Trials, Contraindication, Dermatology, NHS Scotland, Science, Patient, Medication, Atopic dermatitis, III, Adult, AD, Research, DKK, National Institute for Health and Care Excellence, National Institute, CSA, EC, Epidemiology, European Commission, Disease, Health care, NHS England, Dermatitis, MHRA, FAD, LEO, NICE, Scotland, United Arab Emirates, Royal commission, SMC, Leo Pharma, NOS, Safety, TCS, Healthcare Improvement Scotland, A, Pharmaceutical industry, Medical device, Fine chemical, Vaccine, Tralokinumab

Adtralza also is approved for use in Canada, the United Arab Emirates, and Switzerland, and in the United States under the tradename AdbryTM.

Key Points: 
  • Adtralza also is approved for use in Canada, the United Arab Emirates, and Switzerland, and in the United States under the tradename AdbryTM.
  • In January 2022, the Scottish Medicines Consortium (SMC) decided to reimburse Adtralza for use within NHS Scotland.
  • LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world.
  • Final appraisal document | Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis.