Keryx, Torii commence phase-3 trial for Zerenex in Japan
NEW YORK — A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.
Keryx Biopharmaceuticals and Torii Pharmaceutical, the pharmaceuticals subsidiary of Japan Tobacco, started a phase-3 trial of Zerenex (ferric citrate) in Japan for patients with hyperphosphatemia. The drug also is in phase-3 trials in the United States as a treatment for hyperphosphatemia in patients with end-stage kidney disease on dialysis.
“We congratulate our partner, JT/Torii, on the initiation of the phase-3 program in Japan and are excited by their progress,” Keryx CEO Ron Bentsur said. “We believe that this serves to further validate the commercial potential for Zerenex worldwide.”
Lilly receives complete response letter for liprotamase
INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.
The FDA issued a complete response letter to Lilly related to its application for liprotamase, a pancreatic enzyme replacement therapy for exocrine pancreatic insufficiency, requesting that the drug maker conduct an additional clinical trial before resubmitting its application. The FDA issues a complete response letter when it has finished reviewing the application for a drug, but issues remain that preclude final approval.
“Lilly is looking forward to further discussion with the FDA to address the items outlined in the letter and provide the requested information as quickly as possible,” Lilly VP autoimmune, bone-muscle-joint and liprotamase product development Eiry Roberts said. “We are committed to working with the agency and the cystic fibrosis community to make this important treatment available to patients.”
Albertson’s LLC announces participation in Diabetes Prevention and Control Alliance
BOISE, Idaho — Albertson’s LLC, which operates more than 200 stores across seven states under the Albertsons banner, announced it has joined the Diabetes Prevention and Control Alliance.
The retail grocery chain joins such companies as UnitedHealth Group, YMCA, Walgreens and Novo Nordisk as a DPCA partner. Albertson’s LLC will participate in the DCPA’s Diabetes Control Program, offering its customers community-based programs that help prevent and control diabetes.
In-store pharmacists in select Albertson’s LLC locations will conduct blood-glucose, cholesterol and blood-pressure testing services for program participants. Additionally, the in-store pharmacists will provide the participants with on-the-spot results, enabling patients to get immediate feedback on their status or progress in managing their diabetes.
The company now is offering the program at stores in Phoenix and Tucson, and will offer the program throughout other stores later this year.
“Diabetes is becoming increasingly pervasive in the United States and in the communities we serve,” said Raymond McCall, VP pharmacy operations for Albertson’s LLC. “By participating in the Diabetes Prevention and Control Alliance, we are able to offer more specific disease management to participating patients that will help them control their diabetes and maintain a healthy lifestyle.”