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Monthly Archives: March 2013

FDA OKs first-of-its-kind diabetes drug from J&J

WASHINGTON (AP) — The Food and Drug Administration on Friday 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, which affects an estimated 26 million Americans. 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. Regulators highlighted the drug as the first in a new class of medications that could help address the nation’s growing diabetes epidemic.

Analysts estimate Invokana could eventually grow into a blockbuster drug, generating more than $1 billion in sales annually for New Brunswick, N.J.-based J&J.

Invokana differs from older drugs that work by shrinking the amount of sugar absorbed from food and stored in the liver. 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.

The drug also can cause a sudden drop in blood pressure when a patient stands up, which can lead to dizziness or fainting, according to the FDA.

The FDA said it approved the drug based on nine studies involving more than 10,000 patients. The studies showed that Invokana, both alone and in combination with other diabetes drugs, helped control blood sugar levels.

“We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health,” said Dr. Mary Parks, director of the FDA’s division of endocrinology products.

Regulators are requiring Johnson & Johnson to conduct five follow-up studies to assure the drug’s safety. The company will track rates […]

By |March 30th, 2013|blogs|0 Comments

FDA OKs first-of-its-kind diabetes drug from J&J

WASHINGTON (AP) — The Food and Drug Administration on Friday 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, which affects an estimated 26 million Americans. 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. Regulators highlighted the drug as the first in a new class of medications that could help address the nation’s growing diabetes epidemic.

Analysts estimate Invokana could eventually grow into a blockbuster drug, generating more than $1 billion in sales annually for New Brunswick, N.J.-based J&J.

Invokana differs from older drugs that work by shrinking the amount of sugar absorbed from food and stored in the liver. 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.

The drug also can cause a sudden drop in blood pressure when a patient stands up, which can lead to dizziness or fainting, according to the FDA.

The FDA said it approved the drug based on nine studies involving more than 10,000 patients. The studies showed that Invokana, both alone and in combination with other diabetes drugs, helped control blood sugar levels.

“We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health,” said Dr. Mary Parks, director of the FDA’s division of endocrinology products.

Regulators are requiring Johnson & Johnson to conduct five follow-up studies to assure the drug’s safety. The company will track rates […]

By |March 30th, 2013|blogs|0 Comments

FDA approves Johnson & Johnson diabetes drug, canagliflozin

By Toni Clarke

(Reuters) – FDA has approved a new diabetes drug from Johnson & Johnson, making it the first in its class to be approved in the United States.

The U.S. Food and Drug Administration approved the drug, Invokana, after data showed it was effective in lowering blood sugar in patients with Type 2 diabetes, the most common form of the disease.

The FDA has asked for five postmarketing studies for the drug including a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study and two pediatric studies, the agency said in a statement on its website. (http://r.reuters.com/juj96t)

Invokana is expected to generate sales in 2016 of around $468 million, according to analysts’ estimates compiled by Thomson Reuters.

Known chemically as canagliflozin, Invokana is a member of a new class of diabetes treatments called sodium-glucose co-transporter-2 (SGLT2) inhibitors that lower blood sugar by blocking reabsorbtion of glucose and increasing its excretion in urine.

Earlier this year, an advisory committee to the FDA discussed the benefits and risks of canagliflozin with a focus on any potential increased risk of heart attack or stroke.

[…]

By |March 30th, 2013|blogs|0 Comments

FDA OKs first-of-its-kind diabetes drug from J&J

WASHINGTON (AP) — The Food and Drug Administration on Friday 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, which affects an estimated 26 million Americans. 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. Regulators highlighted the drug as the first in a new class of medications that could help address the nation’s growing diabetes epidemic.

Analysts estimate Invokana could eventually grow into a blockbuster drug, generating more than $1 billion in sales annually for New Brunswick, N.J.-based 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 for heart attacks, kidney problems, blindness and other serious complications. Diabetics often require multiple drugs with different mechanisms of action to control their blood sugar levels.

Invokana differs from older drugs that work by shrinking the amount of sugar absorbed from food and stored in the liver. 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. The drug also can cause a sudden drop in blood pressure when a patient stands up, which can lead to dizziness or fainting, according to the FDA.

The FDA said it approved the drug based […]

By |March 30th, 2013|blogs|0 Comments

FDA OKs first-of-a-kind diabetes drug from J&J

WASHINGTON (AP) — The Food and Drug Administration says it has approved a first-of-a-kind diabetes drug from Johnson & Johnson that uses a new method to lower blood sugar.

The agency cleared J&J’s Invokana tablets for adults with Type 2 diabetes, which affects about 26 million Americans.

The drug is a once-a-day medicine designed to lower blood sugar levels in patients by eliminating more sugar in their urine. The drug works by blocking the reabsorption of sugar by the kidneys, which occurs at higher levels in patients with diabetes.

J&J has touted the drug as the first in a new class of medications to help address the nation’s growing diabetes epidemic. The drug differs from older drugs that work by decreasing the amount of sugar absorbed from food and stored in the liver.

By |March 30th, 2013|blogs|0 Comments