FDA approves Kalbitor for hereditary angioedema. Biotherapeutic drug company Dyax Corp. said Tuesday it received Food and Drug Administration approval to market Kalbitor [ecallantide] for treatment of the genetic disorder hereditary angioedema in patients 16 years and up. In patients with "the rare disorder," fluids accumulate "outside the blood vessels, which causes swelling in extremities, the intestinal tract, or airway."
The company said it entered a three-year deal with AmerisourceBergen Corp., a drug wholesaler, to set up an exclusive distribution network and call-center services for the drug. The FDA denied approval of the drug in March, seeking more safety data.
FDA approves OTC version of Zegerid. Merck & Co. and Santarus Inc. Reported that the Food and Drug Administration approved Merck's over-the-counter version of the Santarus prescription heartburn drug Zegerid [omeprazole and sodium bicarbonate]." For its part, Santarus "stands to receive a $20 million milestone must pay royalties on net sales of the over-the-counter drug to the University of Missouri.
FDA requests more research on Ampligen to treat CFS. Hemispherx Biopharma Inc. said the FDA "requested more research on its experimental treatment Ampligen." The company said two clinical studies "submitted with a new drug application for Ampligen, designed to treat chronic fatigue syndrome, weren't sufficient to prove the drug's efficacy" to the FDA, which also "requested at least one more study to show the drug works and to confirm its safety." The FDA also requested that Hemispherx resolve inspection issues at some of its manufacturing facilities that produce Ampligen.
Aspirin therapy may raise recurrent peptic ulcer bleeding risk, lower mortality rates. Continuous low-dose aspirin therapy may increase the risk for recurrent peptic ulcer bleeding, but potentially lowers mortality rates, according to a paper in the Annals of Internal Medicine. Researchers in Hong Kong explained that "aspirin has been increasingly used as a treatment of cardiovascular and cerebrovascular diseases," but "it causes a two- to three-fold increase in the risk for dose-related peptic ulcer bleeding." Hence, the need for the current study in which, as expected, investigators observed that the "main endpoint of recurrent ulcer bleeding within 30 days occurred in 10.3% in the aspirin group and 5.4% in the placebo group." Still, "compared with patients who received placebo, patients who received aspirin had lower all-cause mortality rates."
Lead investigator Dr. Joseph JY Sung was also quick to point out that "the possibility that the difference in all-cause mortality is merely [due to] chance cannot be excluded. Along those lines, Dr. Dominick Angiolillo, of the University of Florida, maintains that "the mortality differences seen by Sung, et al., 'need to be taken with a grain of salt,'" considering it "is a secondary end point." The "other thing to keep in mind is that the study outcomes were evaluated out to eight weeks, and we do know that with bleeding, there can be potential clinical implications even long-term, beyond the eight weeks." Nevertheless, "cardiologists and gastroenterologists should be aware that there is a likelihood of increasing risk of cardiovascular death if aspirin is withheld for a prolonged period."