GlaxoSmithKline receives approval in Japan for two medicines: Revolade and Xyzal

GlaxoSmithKlineGlaxoSmithKline (GSK) announced that it has received approval in Japan from the Ministry of Health, Labour and Welfare for Revolade (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP), and for Xyzal (levocetirizine dihydrochloride), the first new anti-histamine to be made available in Japan for eight years.

Revolade is the world's first oral treatment that stimulates the production of blood platelets, which are essential to normal clotting. ITP patients experience bruising and bleeding and, in some cases, serious haemorrhages, which can be fatal. ITP may also affect a patient’s quality of life, as it is often associated with fatigue and depression and a fear of bleeding may limit everyday activities.

The anti-allergic drug, Xyzal, has been approved for the treatment of allergic rhinitis, urticaria, eczema and dermatitis, prurigo, and cutaneous pruritus in patients over the age of seven years.

Philippe Fauchet, President of GSK Japan, commented, "These approvals are very important to GSK as they demonstrate the progress we are making in gaining approvals in Japan for products that we believe can offer real value to patients. I believe this illustrates GSK's commitment to actively developing treatments for diseases that affect broad groups of patients, such as allergic rhinitis, but also for rare and difficult to treat diseases, where only a small number of patients exist, such as ITP."

About eltrombopag
Eltrombopag was given accelerated approval by the US Food and Drug Administration (FDA) under the trade name Promacta® in November 2008, for the treatment of chronic ITP in adults who have had an insufficient response to corticosteroids, immunoglobulins or following surgical removal of the spleen. It was approved for use in Europe in March 2010 under the trade name Revolade as an oral treatment for thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals (NASDAQ: LGND), and developed by GSK.

About levocetirizine dihydrochloride
Levocetirizine dihydrochloride was developed by UCB and, since its approval in Germany in 2001, has been approved for the treatment of allergic diseases in over 90 countries worldwide including EU countries and the US. GSK acquired rights for the product in Japan and filed for approval in December 2008.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Most Popular Now

Pfizer's elranatamab granted FDA Breakthrough Ther…

Pfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administrati...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Sanofi and GSK's next-generation COVID-19 booster …

After the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the vaccine was approved by t...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

GSK announces positive Phase IIa study results for…

GSK plc (LSE/NYSE: GSK) announced positive results from a Phase IIa study demonstrating that GSK3036656, a first-in-class investigational antitubercular agent, was well t...

New drug shows promise for fighting both COVID-19 …

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot ...

Machine learning can help predict patient response…

Predicting which patients will respond well to treatment is a quandary that has plagued the field of cancer immunotherapy for more than four decades. Now, researchers at ...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...