Sanofi-Aventis receives complete response letter from the FDA for Ciltyri
BRIDGEWATER, N.J. Sanofi-Aventis said that the Food and Drug Administration has issued a complete response letter regarding the company’s new drug application for Ciltyri (eplivanserin).
The drug was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance.
Sanofi-Aventis is currently reviewing the content of the complete response letter, in which the FDA has requested additional information regarding benefit-risk. The company will contact the FDA in the coming days to request a meeting to discuss what steps and data would be needed for approval.
Study finds diabetes drugs do not ease heart disease risk
NEW YORK In patients with recent onset Type 2 diabetes, treatment with insulin or the diabetes drug metformin did not reduce such inflammatory biomarkers as high-sensitivity C-reactive protein, although the treatment did improve glucose control, according to a new study.
The study, which was published in the Sept. 16 issue of the Journal of the American Medical Association, was led by Aruna D. Pradhan, M.D., M.P.H. and colleagues, of Brigham and Women’s Hospital and Harvard Medical School in Boston. The goal was to determine whether insulin alone or combined with metformin lowers levels of hsCRP, IL-6, and sTNFr2 in patients with recent-onset type 2 diabetes mellitus. The study included 500 adults (median [midpoint] time from diabetes diagnosis, 2.0 years), with suboptimal glycemic control and elevated hsCRP levels. Participants were randomized to one of four treatments: placebo metformin only; placebo metformin and insulin; active metformin only; or active metformin and insulin. The researchers noted the change in the measurement of the inflammatory biomarkers from the beginning of the trial to 14 weeks.
The authors wrote that “no consistent association was found between glucose reduction and improvement in inflammatory status ascertained by change in levels of hsCRP, IL-6, or sTNFr2. Despite substantially improving glucose control, neither insulin nor metformin reduced inflammatory biomarker levels for the main effects evaluated or in comparisons between the individual treatment groups. An interaction between interventions was observed such that, compared with no pharmacologic intervention, those allocated to insulin alone had a significant attenuation of inflammation reduction, an effect not observed among those allocated to metformin and insulin or to metformin alone.”
The authors also added that the data underscore the need of improved therapy adherence by patients to reduce heart disease risks, including exercise and weight management, and statin therapy.
NACDS uses Rapid Response Program to urge DMEPOS legislation
ALEXANDRIA, Va. Responding to a recent column about treatment of diabetes and the healthcare debate, an organization catering to the retail pharmacy industry has implemented its Rapid Response Program.
The National Association of Chain Drug Stores president and CEO Steve Anderson penned a response to Morton Kondracke, the executive editor of Capitol Hill publication Roll Call, following Kondracke’s Sept. 10 column.
“I couldn’t agree more with your thoughts and sentiments,” Anderson said of the column. “However, there is one missing piece in your proposed ‘war’ on diabetes – the role of pharmacists in helping to improve patient health outcomes and the federal regulations that threaten the patient-pharmacist relationship.”
As previously reported by Drug Store News, pharmacy retailers are faced with early October deadlines that will force them to gain accreditation and purchase a surety bond in order to continue selling durable medical equipment, prosthetics, orthotics and supplies to seniors covered by Medicare Part B. Those requirements are imposed by the Centers for Medicare and Medicaid Services, a division of the U.S. Dept. of Health and Human Services, will throw up daunting hurdles that will block many pharmacies from continuing to participate in the sale of medical supplies under Part B, industry advocates warned last week.
“As the face of neighborhood healthcare, pharmacies are extremely concerned that these new onerous requirements could force them out of the Medicare program, disrupting the important pharmacist-patient relationship and the pharmacist-provided services diabetic patients rely on receiving at their community pharmacies,” Anderson wrote. “CMS’ view is similarly dim. According to CMS’ own estimates, over 25,000 DMEPOS suppliers will exit the Medicare program due to these requirements. Unfortunately, many patients could be left without a reliable source of DMEPOS and healthcare services if pharmacies are forced out of the Medicare program.”
NACDS and other pharmacy groups hope that current bipartisan legislation, designed to conditionally exempt pharmacies from the surety bond and accreditation requirements, will take effect.