Biodel seeks FDA approval for diabetes drug
DANBURY, Conn. A maker of treatments for endocrine disorders hopes to receive approval from the Food and Drug Administration for a diabetes drug.
Biodel said Dec. 31 it submitted a new drug application to the FDA requesting clearance to market a formulation of recombinant human insulin as a treatment for diabetes.
Biodel said that VIAject has been tested in more than 880 patients who participated in phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. The company is asking the FDA to approve marketing of VIAject as an injectable liquid. According to Biodel, VIAject is designed to be absorbed into the blood faster than currently offered rapid-acting insulin analogs.
“We believe our studies demonstrate that patients receiving VIAject had faster reductions in blood glucose activity, reduced risks of hyperglycemia and hypoglycemia and less weight gain than patients who received recombinant human insulin, and that VIAject may offer important clinical benefits to people with diabetes,” said Biodel chairman and CEO Sol Steiner.
Healthcare IT will help seniors stay compliant, report says
OAKLAND, Calif. A new report from the Center for Technology and Aging, based here in Oakland, suggests that information technology will be critical to improving medication adherence and reducing adverse effects among older adults, potentially saving tens of thousands of lives and billions of dollars.
The white paper, which first emerged in October, addresses three opportunities to improve medication compliance and persistence, including:
• Medication reconciliation, comparing medications a patient is taking against new physician orders;• Medication adherence, and• Medication monitoring. Within each area technologies being used or under development are described, along with an assessment of their pros, cons, market stage and economics.
The report identifies examples of cutting edge technology innovations that are addressing these types of opportunities, including:
• Medication kiosks, such as those piloted at the Veterans Health Administration;• Walgreen’s online medication history tool;• Cognitive assessment tests like the Mini-Mental State Exam (MMSE);• “Rex,” the talking pill bottle designed by Pittsburgh-based MedivoxRx for visually, and cognitively impaired patients;• The Med-eMonitor System, the portable electronic medication-dispensing device from Rockville, Md.-based InforMedix;• Mobile phone apps with medication management, reporting and trending features; and• Wireless point-of-care testing devices to monitor medication use.
“Medication nonadherence is responsible for up to 33% to 69% of medication-related hospital admissions and 23% of all nursing home admissions,” said David Lindeman, director, Center for Technology and Aging. “As Congress debates ways to improve our healthcare system and lower costs, it will be critical to put in place incentives that encourage providers to accelerate the use of available ‘med-op’ technologies.”
Biopharm maker Vivus submits NDA for new obesity drug
MOUNTAIN VIEW, Calif. Vivus, a biopharmaceutical company focused on unmet needs in obesity, diabetes and sexual health, announced Tuesday that it has filed a New Drug Application to the Food and Drug Administration for approval of Qnexa, a new, investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with such co-morbidities as hypertension, Type 2 diabetes, dyslipidemia or central adiposity.
The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two, year-long phase 3 studies, EQUIP and CONQUER. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management, the company stated. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors, according to the study.
“The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities,” noted Leland Wilson, CEO, Vivus. “The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries.”
According to Vivus, other highlights from the two 56-week EQUIP and CONQUER studies — which comprised more than 3,750 patients — included:
- Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;
- FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program;
- Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; and
- Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.