FDA declines to approve Bydureon
INDIANAPOLIS The Food and Drug Administration declined to approve a long-anticipated diabetes drug made by Eli Lilly and two other companies, the companies said Tuesday.
Lilly, Amylin Pharmaceuticals and Alkermes said the FDA issued them a complete response letter for their application for Bydureon (exenatide), a once-weekly version of the Type 2 diabetes drug Byetta. A complete response letter means that the FDA has completed review of a regulatory application, but issues remain that preclude approval.
Specifically, the FDA requested a study showing the effects of higher-than-usual exposures to the drug on patients’ heart rates. The agency also asked for additional data on the safety and effectiveness of Bydureon.
The three companies said they hope to file for approval again by the end of next year. They said the resubmission likely will require a six-month review.
Byetta faces competition from Novo Nordisk’s Victoza (liraglutide), as both drugs are injected daily and belong to the same drug class, known as GLP-1 analogues, which work by stimulating production of the hormone glucagon-like peptide-1. Had it won approval, Bydureon would have given Lilly and the others an advantage due to its more convenient dosing schedule, but the FDA’s complete response letter means Victoza will have a longer period of time in which to take a share of the market from Byetta.
Dr. Reddy’s to launch generic Prevacid
HYDERABAD, India Dr. Reddy’s disclosed on Tuesday it will market a generic peptic ulcer treatment.
Dr. Reddy’s lansoprazole delayed-release capsules will be available in 15-mg and 30-mg strengths, the drug maker said. The capsules are the generic version of Takeda’s Prevacid delayed-release capsules.
The FDA approved Dr. Reddy’s abbreviated new drug application for the drug on Oct. 15.
Kinney Drugs’ pharmacists address compliance issues
GOUVERNEUR, N.Y. October is American Pharmacists Month, and Kinney Drugs has spent it educating patients about the medicines they take and how a relationship with their pharmacist can ensure the safety and efficacy of their therapies, the regional chain said Tuesday.
Poor medication adherence is estimated to cost the healthcare system $290 billion a year, according to the New England Healthcare Institute, while healthcare market research firm IMS Health estimated that only 25% to 30% of new prescriptions are properly taken.
“Compliance is driven by access and affordability, and it’s easy to be noncompliant when people have to make purchasing decisions, they can’t get to the pharmacy or they are not fully informed about their medication,” Kinney Drugs pharmacy director Mike Duteau said. “Pharmacists can make it easier for people to understand their health care and the value of taking medications as prescribed by their doctors.”
The company is highlighting some of the programs it offers, such as e-prescribing, prescription discount plans, automatic refills, flu immunizations and free Medicare Part D consultations. Kinney will sponsor a Community Medicine Take Back event on Wednesday, designed to help customers dispose of medications in a safe and environmentally sound way.