Bristol-Myers, AstraZeneca Receive FDA Approval For Diabetes Drug.
The AP (11/5) reported, “Drug makers Bristol-Myers Squibb Co. and AstraZeneca PLC said Friday that they received US marketing approval for a once-a-day diabetes drug that combines the starter diabetes drug metformin with the companies’ newer drug Onglyza.” The Food and Drug Administration “approved Kombiglyze XR as a treatment for type 2 diabetes in adults.” Kombiglyze is “intended for use along with diet and exercise and has not been studied as a treatment for type 1 diabetes or in combination with insulin, the companies said.”
        Bloomberg News (11/5, Randall) reported, “Bristol-Myers, based in New York, and London-based AstraZeneca have been working together on diabetes drugs since January 2007.” Approximately “24 million Americans have the condition, which occurs when people don’t have enough insulin, limiting their ability to convert blood sugar to energy.” Onglyza “competes with Whitehouse Station, New Jersey-based Merck & Co.’s Januvia in a category of medicines called DPP-4 inhibitors that spur the pancreas to make more insulin and cause the liver to produce less glucose.” The Wall Street Journal /Dow Jones Newswire (11/5) and MedPage Today (11/5) also reported the story.

Technorati Tags: diet, exercise, type ii diabetes

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Global research and advisory firm Decision Resources has predicted that the Chinese type 2 diabetes market will grow from $1.4 billion in 2009 to $2.5 billion in 2014. According to the Emerging Markets report entitled Type 2 Diabetes in China, this growth is attributed to an increasing drug-treated population, expanding medical insurance coverage and the launch and adoption of new drugs in the market.

“China now has the largest type 2 diabetes patient population in the world, and is the third largest market for type 2 diabetes agents, behind the United States and Japan,” said Decision Resources Analyst Jing Wu, M.S., M.B.A. “The type 2 diabetes market in China will continue to grow between 2009 and 2014 at an annual rate of 13 percent, which is faster than expected growth in the US or Japan.”

The report also finds that rising sales from newly launched Western-branded products will offset the generic erosion from older agents. The launches of three dipeptidyl peptidase-4 (DPP-IV) inhibitors—Merck’s Januvia, Novartis’s Galvus and Bristol-Myers Squibb/AstraZeneca’s Onglyza—and two glucagon-like peptide 1 (GLP-1) analogues—Novo Nordisk’s Victoza and Eli Lilly/Amylin/Alkerme’s Bydureon—between 2009 and 2014 will result in more than $270 million combined sales from these two drug classes in 2014.

“Increasing economic power in China and improvements in health insurance coverage has resulted in increased access to healthcare and the ability to afford expensive Western-branded drugs,” said Wu. “While metformin will continue to be the most widely prescribed agent in China because of its low cost and long-term physician familiarity, newly launched DPP-IV inhibitors and GLP-1 agonists will be used more frequently in the second or third line. The use of more Western brands will contribute to the expansion of the type 2 diabetes market in China.”

The new report features extensive primary research of Chinese endocrinologists in Beijing, Shanghai, Guangzhou, Tianjin and Wuhan as well as epidemiology data.

Technorati Tags: china, health, type 2 diabetes

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Agency working with trade associations to increase company vigilance and protect public

In a letter sent today to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

“These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” said FDA Commissioner Margaret A. Hamburg, M.D. “The manufacturers selling these tainted products are operating outside the law.”

The FDA is seeking input and collaboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg.

The agency also announced a new RSS feed¹ to warn consumers more quickly about tainted products marketed as dietary supplements.

The FDA has noted the three most common categories of these illegal products:

• Weight loss products² containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn³ from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty⁴, Solo Slim⁵, Slim-30⁶, and others, which contain sibutramine or closely related drugs (analogs).
• Body-building products⁷ containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
• Sexual enhancement products⁸ that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25⁹, Duro Extend Capsules for Men¹⁰, Magic Power Coffee¹¹, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution.

Lawful dietary supplements contain minerals, vitamins or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Unlike drugs, dietary supplements do not have to be approved by the FDA prior to marketing. Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.

For more information:

Letter to Industry: http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/UCM236985.pdf¹²

Tainted Products Marketed as Dietary Supplements: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm ¹³

RSS Feed: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml¹⁴

Tainted Body Building Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234523.htm¹⁵

Tainted Sexual Enhancement Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234539.htm¹⁶

Tainted Weight Loss Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234592.htm¹⁷

Photos of Tainted Products Marketed as Dietary Supplements: http://www.flickr.com/photos/fdaphotos/sets/72157625502079212/¹⁸

Dietary Supplements: http://www.fda.gov/Food/DietarySupplements/default.htm

Technorati Tags: diet, health, health supplements, weight loss

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For those taking drugs that lower cholesterol, the article below is useful…

The U.S. Food and Drug Administration today reaffirmed its position that elevated amounts of low-density lipoprotein (LDL), or “bad cholesterol,” are a risk factor for cardiovascular diseases such as heart attack, stroke and sudden death and that lowering LDL cholesterol reduces the risk of these diseases.

FDA’s comments are contained in an update to its Jan. 25, 2008, Early Communication describing the agency’s review of data from ENHANCE, a clinical trial comparing Zocor (simvastatin), a drug that lowers cholesterol production in the liver, to Vytorin, a drug that combines Zocor with another drug, Zetia (ezemtimibe), which inhibits cholesterol absorption.

Preliminary results from ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) had indicated there was no significant difference between Vytorin and Zocor-treated patients in the thickness of the walls of the blood vessels of the neck (the carotid arteries) although there was greater lowering of the amount of LDL cholesterol in patients with Vytorin compared to Zocor.

Measuring the thickness of the carotid arteries via ultrasound imaging is considered a biomarker of risk for cardiovascular disease.

FDA has now completed its review of the final clinical trial report of ENHANCE. After two years of treatment, there was no significant difference in carotid artery thickness between Vytorin patients and Zocor patients. However, the levels of LDL cholesterol, decreased by 56% in the Vytorin group and decreased by 39% in the Zocor group.
The results from ENHANCE do not change FDA’s position on the benefits of lowering LDL cholesterol. Based on currently available data, patients should not stop taking Vytorin or other cholesterol-lowering drugs and should talk to their doctor or other health care professional if they have any questions about Vytorin, Zetia or the ENHANCE trial.

FDA’s Early Communications are disclosures that the agency has begun evaluating new data about a drug and is considering regulatory action, but has yet to reach a conclusion.

The update is posted on FDA’s Web site.

RSS Feed for FDA News Releases

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