Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner GlaxoSmithKline plc announced today that it has submitted regulatory applications in the United States and European Union related to eltrombopag (Promacta®/Revolade®) and its use to increase platelet counts in patients with chronic hepatitis C virus infection and low platelets (thrombocytopenia), specifically:
- A supplemental New Drug Application to the US Food and Drug Administration for Promacta (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and to optimize interferon-based therapy.
- A variation to the Marketing Authorization Application to the European Medicines Agency for Revolade (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferon-based therapy.
“We commend GSK for their excellent work and strong commitment to developing a therapy to enable the sickest patients with Hepatitis C to have potential new treatment options. This is a very important, underserved medical market. The recent successful pivotal trials and now submission of the regulatory applications represent significant milestones for the ongoing commercialization of Promacta/Revolade and, importantly, for adult patients with chronic hepatitis C virus infection and thrombocytopenia. We look forward to the completion of the regulatory review,” said John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals.
About eltrombopag (Promacta®/Revolade®)
Eltrombopag, known by the brand name Promacta in the United States and Revolade in the European Union and other countries, is currently approved in 88 countries around the world as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia. Important Safety Information: Promacta may cause hepatotoxicity. Other risks for Promacta include: bone marrow reticulin formation and risk for bone marrow fibrosis, thrombotic/thromboembolic complications, hematologic malignancies, and cataracts.About Ligand Pharmaceuticals Ligand is a biopharmaceutical company with a business model that is based upon the concept of developing or acquiring royalty revenue generating assets and coupling them to a lean corporate cost structure. Ligand’s goal is to produce a bottom line that supports a sustainably profitable business. By diversifying the portfolio of assets across numerous technology types, therapeutic areas, drug targets, and industry partners, we offer investors an opportunity to invest in the increasingly complicated and unpredictable pharmaceutical industry. In comparison to its peers, we believe Ligand has assembled one of the largest and most diversified asset portfolios in the industry with the potential to generate revenue in the future. These therapies address the unmet medical needs of patients for a broad spectrum of diseases including diabetes, hepatitis, muscle wasting, Alzheimer's disease, dyslipidemia, anemia, asthma and osteoporosis. Ligand’s Captisol platform technology is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline, Merck, Pfizer, Eli Lilly & Company, Baxter International, Bristol-Myers Squibb, Celgene, Onyx Pharmaceuticals, Lundbeck Inc., The Medicines Company, Curis, Inc. and Rib-X Pharmaceuticals. Please visit www.captisol.com for more information on Captisol. For more information on Ligand, please visit www.ligand.com. Follow Ligand on Twitter @Ligand_LGND.