New Pill flushes sugar from kidneys!

A fortnight ago, the US Food and Drug Administration  approved a first-of-its-kind diabetes drug from Johnson & Johnson that uses a new method to lower blood sugar — flushing it out in patients’ urine.

The agency cleared J&J’s Invokana tablets for adults with Type-2 diabetes. The once-a-day medication works by blocking the kidneys from reabsorbing sugar, which occurs at higher levels in patients with diabetes than in healthy patients.inokana

Regulators highlighted the drug as the first in a new class of medications that could help address the growing diabetes epidemic. Analysts estimate Invokana could eventually grow into a blockbuster drug, generating more than $1 billion in sales annually for J&J.

People with Type-2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or have become resistant to the hormone, which controls blood sugar levels.

These patients are at higher risk of heart attacks, kidney problems, blindness and other serious complications.

Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels.

Invokana has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone, and insulin. Invokana should not be used to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); or in those with severe renal impairment, end stage renal disease, or in patients on dialysis.

The FDA is requiring five postmarketing studies for Invokana: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Hold on, though, don’t dash to the store just yet…read the fine print:

The most common side effects of Invokana are vaginal yeast infection (vulvovaginal candidiasis) and urinary tract infection.

Because Invokana is associated with a diuretic effect, it can cause a reduction in intravascular volume leading to orthostatic or postural hypotension (a sudden fall in blood pressure when standing up). This may result in symptoms such as dizziness or fainting, and is most common in the first three months of therapy.

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Posted by on April 10, 2013. Filed under Breaking News,HEALTH. You can follow any responses to this entry through the RSS 2.0. Both comments and pings are currently closed.

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