New Diabetes Drug Causes Heart Risk Yet Still Viable Option

New Diabetes Drug Causes Heart Risk Yet Still Viable OptionA new family of medications could soon be on the market for Type 2 Diabetic patients, if the FDA believes that Johnson & Johnson’s new pill could be more of a health benefit to the patients, despite the concern over the heart risks the pill carries.

Studies for the drug canagliflozin, which expels sugar in the urine after it’s filtered from blood by the kidneys, has shown a potentially higher risk for heart events in the first 30 days compared with a placebo, the Food and Drug Administration has announced, yet some believe it may still be a viable option.

The once-a-day pill is J&J’s effort to be the first to market with a new class of diabetes treatments – known as SGLT2 inhibitors – aimed at cutting side effects from current drugs. The drugs also are being developed by Eli Lilly & Co., Boehringer Ingelheim, Bristol-Myers Squibb Co. and AstraZeneca.

A delay to further assess risk “could erase its first mover advantage,” Lawrence Biegelsen, an analyst with Wells Fargo Securities in New York, wrote in a note to clients this week. “A first-to-market position is an important marketing advantage in this arena.”

Canagliflozin may generate $446 million in sales in 2016 if approved, according to the average of three analysts’ estimates compiled by Bloomberg.

The drugmaker has proposed marketing canagliflozin under the name Invokana for adults with Type 2 diabetes. It worked as well against diabetes in clinical trials as Januvia, Merck & Co.’s second-best-selling drug, and a generic treatment called Glimepiride, FDA staff said.

“Results … suggest that canagliflozin has the potential to help control blood sugar levels in a wide range of people with Type 2 diabetes while also offering other possible benefits like weight loss and reductions in blood pressure,” said Ernie Knewitz, a spokesman for Janssen, the J&J unit developing canagliflozin.

J&J submitted interim results of a study called Canvas on the medicine’s cardiovascular effects, showing that canagliflozin also reduced blood pressure.

The studies reviewed so far showed that during the first 30 days of the cardiovascular trial, 13 cardiovascular events occurred on canagliflozin and one on placebo, according to the FDA staff. The drug raises LDL, or bad cholesterol, which may lead to the heart risk, despite favorable changes in HDL, or good cholesterol, blood pressure and body weight, staff said.

“It is unclear whether this is a spurious finding or a true increased risk of early CV (cardiovascular) events,” staff said.

Additional follow-up may not address the signals of early heart risk and the FDA may decide to manage the harm through labeling, Biegelsen said. There is still a possibility that the FDA may wait until full data from the Canvas study becomes available in April, he said.

There are 11 groups of diabetes drugs on the market, said Osama Hamdy, director of the obesity and inpatient diabetes programs at the Joslin Diabetes Center, affiliated with Harvard Medical School in Boston. Most of the treatments stimulate the pancreas to secrete insulin or improve the body’s sensitivity to insulin, a hormone that helps control blood sugar.

SGLT2 inhibitors, like the one J&J developed, don’t cause low blood sugar or weight gain, and because they’re the first to work on the kidney, they can be combined with any other diabetes medication for maximum effect, Hamdy said by phone.

“As a class of drugs available for Type 2 diabetes treatment, this is a welcome option,” the American Diabetes Association, based in Alexandria, Va., said in a statement.

Regulators are scheduled to recommend whether to approve the drug by the end of March.


, , , , , , ,

No comments yet.

Leave a Reply

  • This field is for validation purposes and should be left unchanged.
Latest Drug Injury News

Paxil Possibly Linked To Breast Cancer Risk

Cancer researchers from the City of Hope National Medical Center announced a possible link between Paxil and breast cancer. Research focused on Paxil’s estrogen effect Researchers found that Paxil has a weak estrogen effect that could increase women’s breast cancer risks. According to lead author and chairman of City of Hope’s Department of Cancer and […]

Big Pharma under Fire for Kickbacks to Docs

Trust and honesty are the cornerstones to a doctor-patient relationship. With so many doctors receiving financial incentives to use certain medications or medical devices, patients need to know if money drives the decision making process. Doctors are required to disclose potential financial conflicts to each other at conferences, but there currently is no law forcing […]

Dietary Supplements Damage Liver

A recent study revealed a significant increase in liver damage related to dietary supplements. The study, conducted by a national network of liver specialists, found a 13% increase in serious liver damage over a 10 year span. Some of these patients required liver transplants and some have even died due to liver failure. Authors of […]

FDA Advisory Committee Supports Approval of Gilead’s HIV Reducing Drug

The pharmaceutical industry may be on the verge of one of the greatest breakthrough’s that this generation has ever seen.

U.S. Health Regulators Issue New Restrictions For Gilenya, Novartis AG’s’ Multiple Sclerosis Pill

In December 2011, the FDA issued a Drug Safety Communication concerning a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

Latest Medical Device Injury News

Report Raises Concerns Over Heart Defibrillator Leads

The Food and Drug Administration (FDA) has just announced that they received a report that a St. Jude Durata cardiac defibrillator lead conductor became externalized; meaning the wire carrying electricity from the heart defibrillator to the heart was exposed through its insulation, a potentially dangerous and life-threatening defect.

HeartSine Class 1 Defibrillator Recall

HeartSine sent out a letter to customers in September, warning that the defibrillators may intermittently turn on and off, eventually depleting the battery.

FDA Medical Device Approval Based On Little Evidence

More than half of the high-risk cardiovascular devices approved in the past decade had no supporting active control data.

St. Jude Medical Gets FDA Warning

St. Jude Medical Inc. said it received a FDA warning about manufacturing and quality-control problems at its Sylmar, California, plant.

Hospira Still Facing Manufacturing And Regulatory Issues

Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections. The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.