Ligand Partner GlaxoSmithKline Announces Priority Review For Supplemental New Drug Application For Promacta® For The Treatment Of Thrombocytopenia In Adult Patients With Chronic Hepatitis C Infection
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today
announced that its partner GlaxoSmithKline (NYSE: GSK) has been granted
priority review from the US Food and Drug Administration for the
supplemental new drug...
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its partner GlaxoSmithKline (NYSE: GSK) has been granted priority review from the US Food and Drug Administration for the supplemental new drug application for Promacta ® to treat thrombocytopenia in adult patients with chronic hepatitis C virus (HCV) infection. A Priority Review designation is given to drugs that if approved, offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under the Prescription Drugs User Fee Act, the goal for completing a Priority Review is six months. 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 89 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.