A 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.
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