Prometheus Laboratories, a specialty pharmaceutical company, has signed an agreement with GlaxoSmithKline to acquire exclusive rights to Lotronex (alosetron hydrochloride) tablets in the US. Lotronex is the only prescription drug approved by the FDA for use in female patients with severe diarrhea-predominant irritable bowel syndrome who meet the conditions stated in the label. Prometheus will market and sell Lotronex under an exclusive distribution agreement until the acquisition is completed, which is expected in January 2008. Prometheus will continue to offer Lotronex exclusively through the currently established prescribing program for Lotronex (PPL). Lotronex may be prescribed only by physicians who have enrolled in the PPL.
The FDA has approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit pose to patients with cancer and patients with chronic kidney failure. The labeling changes, which incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007, also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs. Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer. Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by zidovudine (AZT) therapy in HIV patients.
