Posts Tagged ‘Food and Drug Administration’

FDA Approves Once Weekly Drug for Diabetes; Shows Weight Loss

January 28th, 2012

The Food and Drug Administration has approved Amylin Pharmaceutical’s Bydureon for thetreatment of type 2 diabetes. This is the first once-weekly treatment for type 2 diabetes. It is hoped that this feature will lead to higher adherence to the treatment regimen, although as with Byetta, it is injectable. The drug is exenatide, a GLP-1 receptor agonist. Study results showed an improvement in glycemic control.  A1C levels, a measure of blood sugar, decreased an average of 1.6 points.

Many patients with Type 2 diabetes are also overweight or obese. Many drugs for type 2 diabetes actually cause weight gain. The advantage of Bydureon (and its daily administered counterpart, Byetta) is that patients taking Bydureon can achieve weight loss, in addition to improvements in glycemia, blood pressure, and cholesterol in both overweight and obesity subjects with and without type 2 diabetes. Effects of glucagon-like peptide-1 receptor agonists on … [BMJ. 2012] – PubMed – NCBI

A very small study of 12 children and adolescents with extreme obesity also showed significant improvements, suggesting the need for a larger study. Exenatide as a weight-loss therapy i… [Obesity (Silver Spring). 2012] – PubMed – NCBI

More information is available at www.BYDUREON.com.

Child Food Marketing Guidelines Set Back…Again

December 16th, 2011

Food and beverage industry has won another victory in Congress (did you forget pizza?) , forcing through a provision which would require the three federal agencies involved in writing the new guidelines for marketing to children to undertake a cost benefit analysis. Lawmakers want cost-benefit analysis on child food marketing restrictions – The Washington Post Earlier in the year, the industry had forced the Administration to drastically curtail the age group covered by the proposed guidelines Food giants fight proposed nutrition guidelines – SFGate

Study Raises Prospect of Qnexa Approval

December 15th, 2011

A study published December 7, 2011in the American Journal of Clinical Nutrition provides two-year data on the safety and effectiveness of Vivus Inc.’s drug candidate, Qnexa in patients with cardiometabolic disease.

Qnexa is a combination drug composed of phentermine and topiramate. It was tested in two doses among 676 subjects. Changes in weight were -1.8% for placebo, -9.3% for low dose and -10.5% for the high dose. Significantly more subjects at each dose achieved more than 5%, 10%, 15% and 20% weight loss compared to placebo. Subjects on the drug had improved cardiovascular and metabolic metrics and decreased rates of diabetes. The high dose was significantly better in weight loss among the most severely obese subjects. Adverse events were modest and drop-out rates were similar between placebo and drug groups. There were no deaths. There were two pregnancies. One was carried to term. The other resulted in a miscarriage. The infant was born with no observed birth defects which was a concern of the FDA Advisory Committee which reviewed the drug last year.Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study 

The very impressive weight loss and low side effect profile from this two-year study are expected to improve the odds of approval by the FDA. Another Advisory Committee hearing in early 2012 is expected. 

Consumer Alert – HCG hormone

December 6th, 2011

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters on HCG “homeopathic” products sold over-the-counter for weight loss.  HCG or human chorionic gonadotropin is a hormone produced by the human placenta and found in the urine of pregnant women. It is approved as an injectable prescription drug for female infertility, among other conditions.

The letter warns companies that they are violating federal law by selling drugs that have not been approved and by making unsupported claims. There is no evidence, according to the agencies, that HCG improves weight loss beyond the recommended low calorie diet. For the press release, see Press Announcements > FDA, FTC act to remove “homeopathic” HCG weight loss products from the market

FDA Accepts New Qnexa Petition

November 3rd, 2011

Vivus Inc. announced that the Food and Drug Administration had accepted its New Drug Application for Qnexa™. The FDA expects to have an Advisory Committee hearing in the first quarter of 2012. The proposed labeling includes a contraindication for women of childbearing age. VIVUS, Inc. – FDA Accepts New Drug Application Filing for Qnexa, At the same time, a study was published on Qnexa ™ in 1,267 persons with severe obesity which showed an average weight loss of 14.4% from initial body weight. VIVUS, Inc. – Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment

What’s Up with the FDA? Part 6 – Medical Devices

October 28th, 2011

In mid-October, the Food and Drug Administration Center for Devices and Radiological Health and Massachusetts General Hospital conducted a workshop on device development in obesity and metabolic disease. The two-day program covered clinical trial design, inclusion criteria, outcome targets, device development strategies and regulatory considerations. Perspectives were vigorously offered from the clinical, industry, payer and FDA perspectives.

 A couple of important issues emerged. First, device developers are as frustrated with the FDA as are drug developers. The reasons for the frustration are similar as well: uncertainty over what is clinically meaningful weight loss and the need for a new guidance for device developers which eschew the ‘one size fits all’ approach in favor of a new system which takes into account the invasiveness of the procedure and the expected amount of weight loss and its durability. The FDA is also grappling with the decision to lower the BMI threshold for gastric banding in terms of understanding the benefits of weight loss at lower BMIs.

 An extensive discussion, led by Dr. Lee Kaplan of the Harvard Medical School, focused on why developers were conducting so much research outside of the United States. The answer from the companies and venture capital investors was clear: the delays and uncertainty in the FDA process (“regulatory purgatory” was the term of one participant) cost too much time and money for a small company compared to going to Europe or South America for research and for obtaining the “CE” mark to allow marketing in Europe. The bottom line was that the device industry was looking to move its research and development base (and jobs) outside the US.

IOM Supports Calorie Info on Front of Package

October 22nd, 2011

This week the Institute of Medicine issued its recommendations for Front-of-Package labeling, including specific calorie labeling in common household measures. The recommendation reads:

 Recommendation 1

FDA and USDA should develop, test, and implement a single, standard FOP system to

appear on all products. The system should have the following characteristics:

One simple, standard symbol translating information from the Nutrition Facts

panel (NFP) on each product into a quickly and easily grasped health meaning,

making healthier options unmistakable;

Displaying: Calories in common household measure serving sizes (shelf tags to be

used on bulk items such as fruits and vegetables as well as packaged goods),

and Zero to three nutritional “points” (for saturated and trans fats, sodium,

and added sugars);

Appearing on all grocery products, allowing consumers to compare food

choices across and within categories (determination for universal implementation of the symbol system must be preceded by consumer testing and conducted in conjunction with an education and promotion program);

Appearing in a consistent location across products;

Practical to implement by being consistent with nutrition labeling regulations;

Integrated with the NFP so that the FOP symbol system and the NFP are mutually reinforcing;

Providing a non-proprietary, transparent translation of nutrition information into health meaning; and

Made prominent and useful to consumers through an ongoing and frequently refreshed program of promotion integrating the efforts of all concerned parties.

It will be up to the Food and Drug Administration to act on the IOM recommendations. For background on FOP calorie labeling, see my post.

FDA Warns Consumers on Weight Loss Supplements

October 19th, 2011

The Food and Drug Administration has issued a consumer warning covering 20 weight loss products, specifically dietary supplements, for containing tainted or illegal ingredients. See Medication Health Fraud > Tainted Weight Loss Products