FDA approves first drug of its kind for type 2 diabetes

diabetesOn Friday, the U.S. Food and Drug Administration approved the first of a new type of medication to treat type 2 diabetes. Nearly 26 million people have diabetes in the United States alone, and some 347 million people have the chronic disease worldwide, with type 2 diabetes being the most common form of the condition.

Johnson & Johnson First to Market with New Class of Type 2 Diabetes Drug

Johnson & Johnson received approval from the U.S. FDA on Friday for Invokana, a medication for the treatment of type 2 diabetes in a new class of drugs, sodium-glucose co-transporter 2 inhibitors, or SGLT2 inhibitors, reported USNews.com .

Canaglifozin, the generic name for the new medication, works by blocking the action of SGLT, which allows the blood sugar circulating in the blood to remain in the blood stream during filtration by the kidneys. This medication inhibits that normal process, allowing the kidneys to instead filter out excess blood glucose for excretion in the urine the U.S. FDA explained in its press release.

Invokana received approval after nine clinical trials involving more than 10,000 participants where the drug demonstrated improvement in both fasting blood glucose levels and hemoglobin A1C levels. Fasting blood glucose lab testing measures the about of sugar circulating in the blood that is representative of current blood glucose levels; hemoglobin A1c lab testing provides an average of circulating sugar in the blood over a period of three months. Both are tests that health care providers use as parameters to diagnose and treat diabetes.

Projected Price of Invokana and Drug Sales

Johnson & Johnson has determined the wholesale price of Invokana will be $8.77 per tablet, a price the company said is competitive with other diabetes drugs, according to NYTimes.com .

Johnson & Johnson is currently seeking approval for the new medication in Europe, where it would become the second such drug in its class to dapagliflozin, a Bristol-Myers Squibb and AstraZeneca product that was rejected approval in the United States due to safety concerns.

Sales totaling $111 million in 2013 and up to $667 million by 2016 have been predicted by Lawrence Biegelsen of Wells Fargo.

Potential Side Effects, Safety Concerns with Invokana

The U.S. FDA has required that Johnson & Johnson conduct five post-marketing studies for canaglifozin due to findings that occurred during the initial nice clinical trials, but whose incidence was deemed as not significant to the approval process by the federal agency.

With the information from the nine clinical studies, it is known that taking Invokana may raise a user’s chance of developing vaginal yeast infections and/or urinary tract infections.

The studies will evaluate heart-related outcomes, serious cases of pancreatitis, any malignancies that develop, severe allergic reactions, liver abnormalities, adverse pregnancy outcomes, bone safety, photosensitivity reactions and two pediatric studies. The results of these studies will aid in determination of whether the medication continues to fall within safety standards and what warnings or precautions should be observed with its use.

Baby Boomers at Increased Risk of Developing Type 2 Diabetes

The Journal of the American Medical Association’s Internal Medicine reported results of a study that revealed baby boomers have a higher risk for chronic diseases, including diabetes, than do their parents despite the advances of health care over the lifespan of the boomers. The number of baby boomers who have type 2 diabetes is likely to rise as the generation ages because increasing age and overweight and obesity — prevalent in baby boomers — are risk factors for developing the chronic condition.

Posted by on Apr 1st, 2013 and filed under Health. You can follow any responses to this entry through the RSS 2.0. You can leave a response by filling following comment form or trackback to this entry from your site

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