Biodel receives complete response letter for Linjeta
DANBURY, Conn. The Food and Drug Administration has turned down an application for an insulin product made by Biodel, Biodel said.
The drug maker announced that it received a complete response letter from the FDA for Linjeta (human insulin [rDNA origin]) for the treatment of Type 1 and Type 2 diabetes.
Acomplete response letter means that the FDA has completed review of an application, but questions remain that preclude final approval. Specifically, the FDA brought up issues surrounding data from a trial of Type 1 diabetes patients in India and the insulin’s noninferiority compared with other treatments in Type 2 diabetes patients.
“We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward,” Biodel president and CEO Errol De Souza said. “We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes.”
Medco achieves 10.7% profit growth in Q3
FRANKLIN LAKES, N.J. Pharmacy benefit manager Medco Health Solutions had sales of $16.3 billion, including $2.9 billion from specialty pharmacy operations, the company said Tuesday.
The sales resulted in a profit of $371.5 million, a 10.7% increase over third quarter 2009. Cash flows for the first three quarters of the year were $1.37 billion, a decrease of $1.18 billion compared with last year — the decrease resulting from reductions in inventory. The company expects cash flows for the year as a whole to total $2.4 billion. Earnings per share were 85 cents, which the company called record-breaking for third quarter.
Mail-order prescriptions were 27.3 million, a 7.1% increase over last year, with generic volumes increasing by 15.5%, to 17.1 million. The generic dispensing rate was 71.6%, a 3.9% increase over the same period last year.
NACDS weighs in on FDA priorities, urging simpler med info for patients
ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.
NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.
NACDS, he told Hamburg, strongly endorses FDA efforts to adopt a simpler, single medication information document for patients in order to provide clear, easy-to-understand instructions and warnings about possible side effects, etc., of their prescription medicines. Such a document, Nicholson asserted, provides the “final link in the prescription supply chain,” and should be “standardized with respect to format and content.”
Behind that priority: the need to eliminate confusion and improve patient safety, NACDS agreed. “Today, patients receive several different types of written medication information, developed by different sources that may be duplicative, incomplete or difficult to read and understand,” Nicholson pointed out. “This current system is not adequate to ensure that patients receive essential medication information.”
The NACDS official reminded Hamburg that his group was part of a coalition of pharmacy groups that submitted a citizen petition to the FDA in 2008, urging the agency to require drug suppliers to provide “a concise, plain-language document for patients” when they fill a prescription.
Among the group’s other priorities with the agency: adoption of an abbreviated approval pathway for biogenerics. Nicholson also applauded recent efforts by the FDA’s Center for Drug Evaluation and Research and its director, Janet Woodcock, to address lingering skepticism among “certain sectors of the public” about the therapeutic equivalence of generic drugs.
“We applaud Dr. Woodcock for acknowledging this skepticism and for making its resolution a high priority,” he added.
Nicholson also addressed the issue of safety in the pharmaceutical supply chain, noting that NACDS has long supported state efforts to prevent the entry of adulterated or counterfeit drugs into the distribution pipeline. He urged the FDA to continue its stepped-up efforts to assure the integrity of the drug supply system by pursuing “developing global alliances of regulators, more inspections and updated technology systems to assist the agency with increased workload.
“Our industry has supported state-level legislation requiring enhanced wholesale distributor licensure requirements and chain-of-custody ‘pedigrees’ for drug distributions outside the recognized and sale ‘normal distribution channel,’” Nicholson told Hamburg. To that end, he added, “more than 60% of the states have enacted laws and regulations to strengthen the security for the drug distribution supply chain.”