Teva seeks FDA approval for chemotherapy-induced neutropenia biosimilar
JERUSALEM Teva has filed a regulatory approval application with the Food and Drug Administration for a biosimilar for treating chemotherapy-induced neutropenia, the generic drug maker announced.
Teva said it filed a biologics license application with the FDA for XM02, a biosimilar of Amgen’s Neupogen (filgrastim). XM02 received approval in September 2008 for the European Union, where Teva markets it under the name TevaGrastim.
Chemotherapy-induced neutropenia is a blood disorder that results from an abnormally low number of neutrophils, a type of white blood cell that makes up 50% to 70% of white blood cells circulating in the body and is important in fighting bacteria. Because cancer and chemotherapy can damage the bone marrow and destroy neutrophils.
The application submission is based on results of five clinical studies with more than 680 patients. The main study, conducted on breast cancer patients, compared XM02 with Neupogen and placebo in the first cycle of chemotherapy. Two other trials were conducted on patients with lung cancer and non-Hodgkin’s lymphoma.
“We are pleased to complete the BLA submission for XM02, and as a result, mark a U.S. milestone for us as it is our first biologic product,” Teva North America president and CEO William Marth said. “Teva is dedicated to bringing high-quality and affordable biologics to our customers, including a portfolio of additional follow-on biologic drugs currently in research and development.”
Valeant to acquire Laboratoire Dr. Renaud
ALISO VIEJO, Calif. U.S. drug maker Valeant Pharmaceuticals International will acquire a Canadian cosmeceutical company, Valeant announced Monday.
Valeant Canada will purchase Laval, Quebec-based Laboratoire Dr. Renaud for C$21.8 million, leasing a 45,000-sq.-ft. manufacturing plant for topical products. Dr. Renaud has annual sales of $10.4 million, and the acquisition is expected to be completed in 2010.
“This acquisition is part of our continued efforts to build a leading dermatology business by adding respected brand names in our select regions,” Valeant chairman and CEO J. Michael Pearson stated. “Laboratoire Dr. Renaud enjoys a high degree of loyalty from esthetic clinics and spas, and we believe that Valeant will gain immediate entree into the cosmeceutical market in Canada. With exclusive access to a world class topical manufacturing plant and a successful sales and marketing infrastructure, we also have the ability to launch select U.S. dermatology products into Canada and further expand our reach in dermatology.”
FDA warns GSK’s HIV drug may increase risk of heart attack
ROCKVILLE, Md. The Food and Drug Administration and GlaxoSmithKline have warned healthcare professionals of the risk of heart attack and buildup of cholesterol in patients taking a drug used to treat HIV.
The FDA released an alert Thursday announcing that it had modified the prescription information for the drug Lexiva (fosamprenavir calcium) to note that some patients taking the drug have experienced increases in cholesterol, a condition known as dyslipidemia, and recommend that patients undergo cholesterol and triglyceride testing before and during therapy with the drug.
In other news, the agency warned of possible birth defects among babies born to women who take the epilepsy drug valproate sodium and related drugs during pregnancy, including defects of the head and face and circulatory systems. Valproate sodium and related drugs are mostly available as generics, and Abbott Labs markets them under brand names such as Depacon (valproate sodium injection) and Depakote (divalproex sodium tablets).