FDA committee recommends approval of Xifaxan
RALEIGH, N.C. A Food and Drug Administration committee has recommended approval for a drug to treat a brain disease that results from liver malfunction.
Salix Pharmaceuticals said this week that the FDA’s Gastrointestinal Drugs Advisory Committee had recommended approval of the drug Xifaxan (rifaximin) tablets in the 550-mg strength for maintenance of remission of hepatic encephalopathy. The FDA’s recommendation was based on a review of a 299-patient phase-3 clinical trial of the drug.
The disease often occurs in patients with cirrhosis as a result of end-stage liver disease. Cirrhosis results from such factors as viral hepatitis, autoimmune disease and long-term abuse of drugs and alcohol, affecting more than 600,000 people in the United States.
“We are very pleased with the advisory committee’s support for the approval of Xifaxan 550-mg tablets,” Salix SVP research and development and chief development officer Bill Forbes said. “If approved, Xifaxan 550-mg will be the first new option for the management of hepatic encephalopathy in over 30 years.”
Alliance Health Networks forms healthcare advisory board
SALT LAKE CITY Alliance Health Networks, which is building a universe of social health networks focused on such specific health conditions as diabetes, has formed a healthcare advisory board. Among the founding members: pharmacy industry veteran Gordon Barker.
According to Alliance Health’s CEO, Stead Burwell, the advisory board is designed to provide Alliance Health executive management and its board of directors with industry insights, feedback and strategic counsel in support of its efforts to build online social health networks that bring together patients, caregivers and industry participants.
Alliance Health’s first social health network DiabeticConnect.com, has attracted the largest online population of people living with or treating diabetes, according to the company.
Barker has a nearly 40-year career in the pharmacy industry that includes 30 years with Thrifty PayLess Drug Stores, now Rite Aid. He started there as a pharmacist and eventually became president and CEO. He then served as CEO of Snyder Drug from 2005 through early 2009. In addition, Barker served as chairman of the board of the Juvenile Diabetes Research Found and currently serves on its board of chancellors.
Additional members of the advisory board include McKesson veteran, Richard Hawkins; and Robert Johnson, former chairman and CEO of PCS Health Systems, which is now part of CVS Caremark.
Inhaled CF antibiotic receives FDA approval
BETHESDA, Md. The Food and Drug Administration has approved the first inhaled antibiotic for cystic fibrosis in more than a decade, according to a cystic fibrosis advocacy organization.
The Cystic Fibrosis Foundation announced the FDA’s approval of Cayston (aztreonam), developed by Gilead Sciences. The organization invested $1 million to help development of the drug.
“The approval of Cayston demonstrates that our drug-development model is working and making a real difference in the lives of people with cystic fibrosis,” Cystic Fibrosis Foundation president and CEO Robert Beall said in a statement. “We are delighted to have a new antibiotic in the arsenal to help fight the life-threatening infections associated with this disease, as we continue to push forward with other therapies that address the underlying cause of CF.”