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Invokana 112 articles

SGLT1/SGLT2 inhibitor tested in type 1 diabetics

Clinical trial data for Lexicon Pharmaceuticals’ type 1 diabetes drug is performing well, significantly reducing the marker A1C in 24 weeks as well as through the first full year of treatment, even helping patients lose weight and lower blood pressure, according to Endpoints News. But before the drug is cleared for marketing by the Food and Drug Administration (FDA), the drug company will have to prove that it is safe. The drug is a combination SGLT1/SGLT2 inhibitor called sotagliflozin, which targets SGLT2 within the kidneys as well as SGLT-1 inhibitors located in the intestinal tract. Both work to block glucose ... Read More

CVS boots Jardiance for more risky Invokana

CVS Caremark is booting the type 2 diabetes drug Jardiance as a preferred option in favor of Invokana, despite Invokana showing more adverse events than its competitor. Eli Lilly and Boehringer Ingelheim’s Jardiance, and Johnson & Johnson’s Janssen Pharmaceuticals’ Invokana are in the same drug class known as SGLT2 inhibitors. Both drugs have posted a 14 percent composite reduction in cardiovascular risks in studies, a highly desirable marker for a diabetes drug. But the move by CVS has some analysts scratching their heads. While both drugs provide cardiovascular benefit, many drugs in the class have been rife with adverse events ... Read More

FDA reports reinforce Invokana boxed warning

New data from the Food and Drug Administration’s (FDA) database of adverse events reinforces the black box warning on the type 2 diabetes drug canagliflozin regarding amputation risk, and further indicates that the amputation risk is not a class wide occurrence. Canagliflozin is the active drug ingredient in the brand name medications Invokana and Invokamet, made by Johnson & Johnson’s Janssen Pharmaceuticals. The drug was the first medication approved from a class known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. In May 2017, the FDA required that a boxed warning be added to the labels of canagliflozen after so-called CANVAS studies showed ... Read More

FDA approves boxed warning on Invokana label

The labels of the type 2 diabetes drugs Invokana, Invokana and Invokamet XR have been updated to include a new boxed warning regarding an increased risk of leg and foot amputations, the Food and Drug Administration (FDA) announced. The approved safety label update comes two months after the FDA issued a Safety Communication alerting the public that after a review of clinical trial data, the agency has determined that its strongest warning should be added to the labels of all drugs that contain the active ingredient canagliflozin regarding the amputation risk. Invokana, Invokamet and Invokamet XR all contain canagliflozin. The ... Read More

Jardiance stealing Invokana market share

Johnson & Johnson’s first-in-class diabetes drug Invokana is losing ground to its biggest competitor in the market, FiercePharma reported. The company reported that sales of Invokana fells short of second-quarter forecasts, coming in a tad more than 20 percent below consensus estimates of $371 million. “And that was in a quarter when the overall market expanded by 3.5 percent,” the media source said, referencing the drug company’s projections. Eli Lilly and Co. and Boehiringer Ingelheim’s diabetes medication competitor Jardiance, meanwhile, is gaining ground on the heels of promising cardiovascular data and fewer warnings than Invokana or others in the SGLT2 ... Read More

‘Is there something wrong with Invokana?’

“Is there something wrong with Invokana?” The Motley Fool posed this question as part of a roundup of elements leading up to Johnson & Johnson’s quarterly report, which the media source says “often sets the tone for the pharmaceutical industry.” Johnson & Johnson is expected to produce $18.97 billion in sales – a growth of 2.6 percent over last year’s quarter. But, The Motley Fool says, “there is so much more to pay attention to than just a single sales and profit-per-share figure.” This includes the status of Johnson & Johnson’s top selling diabetes drug Invokana, which is manufactured by subsidiary ... Read More

Invokana may increase kidney stone risk

The Food and Drug Administration (FDA) has determined that no action is needed at this time regarding reports of kidney stones with a popular class of type 2 diabetes drugs called SGLT2 inhibitors, the agency announced in the newly released quarterly (January-March 2017) Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS). The agency had received reports of nephrolithiasis – or kidney stones – in patients taking SGLT2 inhibitors. Brand names include Invokana and Invokamet, as well as Farxiga, Jardiance, Synjardy, and Xigudo XR. When the FDA identifies a potential safety issue, as ... Read More

Invokana sales may suffer after new warnings

Johnson & Johnson and its subsidiary Janssen Pharmaceuticals were relieved to unveil promising cardiovascular outcomes from a study involving their type 2 diabetes medication Invokana at the American Diabetes Conference last month. But while the data shows that patients taking the drug were less likely to suffer from a heart attack or stroke, the numbers were not as impressive as the ones laid out previously by Eli Lilly and Co. and Boehinger Ingelheim for their diabetes treatment Jardiance, BioPharma Dive reports. Even more upsetting is that Invokana was slapped with new warnings in recent weeks, this time for an increased ... Read More

Studies: Invokana amputation risk not classwide

Executives from Boehringer Ingelheim and AstraZeneca announced at the American Diabetes Association’s annual meeting that their type 2 diabetes drugs Jardiance and Farxiga, respectively, may share the same drug class as Janssen Pharmaceuticals’ Invokana, but they do not carry the same amputation risk. In May, following a safety review by the Food and Drug Administration (FDA), the agency concluded that a boxed warning should be placed on packages of Invokana regarding a two-fold risk of amputations in people treated with Invokana. The most common amputations were of the toe and middle of the foot. But, some amputations involved the leg, ... Read More

Jardiance to be tested as kidney disease treatment

Boehringer Ingelheim and Eli Lilly announced plans to test its type 2 diabetes drug Jardiance as a treatment for patients with chronic kidney disease. The study will be conducted in both patients with and without type 2 diabetes, MPR reported. The investigation into Jardiance as a treatment for chronic kidney disease comes from a previous trial not designed to assess the medication’s mechanisms in renal outcomes. But, kidney assessment was part of a pre-specified exploratory analysis of additional endpoints. During that trial, Jardiance was found to lower the risk for new-onset or worsening kidney disease by 39 percent in patients ... Read More