Friday, April 12, 2013

FDA approves first medication of new class to treat diabetes.

The New York Times (3/30, B4, Thomas, Pollack, Subscription Publication, 1.68M) reported that the FDA has "approved the first of a new class of medicines to treat diabetes." The medication, "Invokana [canagliflozin], will be sold by Johnson & Johnson and treats patients with type 2 diabetes in a new way, by causing blood sugar to be excreted in the urine." In a statement, Dr. Mary Parks, who oversees medications for metabolic diseases at the agency, said, "We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions."
        The Wall Street Journal (3/30, Loftus, Tadena, Subscription Publication, 2.29M) pointed out that Invokana is J&J's first FDA-approved prescription medication to treat type 2 diabetes.
        The AP (3/30) reports, "The most common side effects of Invokana are yeast infections and urinary tract infections, due to the higher amounts of sugar passing through a patient's urine." Additionally, the medication "can cause a sudden drop in blood pressure when a patient stands up, which can lead to dizziness or fainting, according to the FDA."
        Bloomberg News (3/30, Edney) reported, "The FDA has required...J&J to conduct five post-market studies to track possible health risks, including to the heart, bones and pancreas." The medication is considered a sodium glucose co-transporter 2 (SGLT2) inhibitor.
        HealthDay (3/30, Preidt) reported, "The FDA approval is based on the findings of nine clinical trials involving more than 10,000 patients. Patients who took the drug showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting blood sugar levels."
        MedPage Today (3/30, Fiore) reported, "The agency warned, however, that canagliflozin is not for use in patients with type 1 diabetes, and is contraindicated in patients who have increased ketones in their blood or urine."
        Heartwire (3/30, Nainggolan) reported, "The authorization follows a 10 to 5 vote in favor of approval of canagliflozin by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in January, despite concerns about the cardiovascular safety of the drug."

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