FDA approves Agriflu
SILVER SPRING, Md. Another flu vaccine has been approved by the Food and Drug Administration.
The FDA announced the approval of Agriflu for adults ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. It is not intended, however, to protect against the 2009 H1N1 influenza.
Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA’s accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.
Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.
“The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.
As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirin is approved for people ages 4 years and older.
FDA accepts NDA for new Aricept formulation
WOODCLIFF LAKE, N.J. Eisai and Pfizer announced that the Food and Drug Administration has accepted for review Eisai’s new drug application for its Alzheimer’s disease treatment.
Once daily 23-mg Aricept (donepezil HCl extended release) tablets is a new higher dose formulation contains 23-mg of donepezil HCl in an extended release, matrix-type tablet with a delivery system that allows for gradual release of the drug. The NDA is based on a head-to-head clinical study comparing the 23-mg Aricept extended release tablet to the currently marketed once daily 10-mg Aricept (donepezil HCl) immediate release tablet. More than 1,400 patients with moderate to severe Alzheimer’s disease were enrolled in this global study.
Acceptance of the NDA indicates that the FDA has found the company’s submission to be sufficiently complete to review. Eisai and Pfizer believe this new formulation will potentially provide physicians, patients and their families with another option for the management of Alzheimer’s disease, the companies stated.
Study finds spike in morbid obesity rates among Type 2 diabetics
NEW YORK A Loyola University Health System study has found that 1-out-of-5 Type 2 diabetics is morbidly obese — approximately 100 lbs. or more overweight.
“The rate of morbid obesity among people with diabetes is increasing at a very alarming rate, and this has substantial public health implications,” said Dr. Holly Kramer, a kidney specialist and lead author of the study published online in the Journal of Diabetes and its Complications.
Kramer and colleagues examined data from the National Health and Nutrition Examination Surveys completed during the years 1976 to 2006. The surveys, known as NHANES, included interviews and physical examinations of representative samples of the U.S. population.
The study found a 141% increase in the rate of morbid obesity among adults with Type 2 diabetes between 1976 to 1980 and 2005 to 2006. More than 60% of U.S. adults with Type 2 diabetes are obese, and 20.7% are morbidly obese. Further, 1-in-3 African-American adults with Type 2 diabetes is morbidly obese.