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Boehringer Ingelheim 36 articles

FDA panel questions study to expand indication for type 2 diabetes drug Jardiance

A Food and Drug Administration (FDA) advisory panel gave a half-hearted recommendation to expand the indication of the type 2 diabetes drug Jardiance (empagliflozin) to include prevention of cardiovascular events, and raised important questions involving a key study used to make those claims. Since 2008, developers of approved type 2 diabetes drugs are required to collect data to rule out an increase in cardiovascular risk. Such was the case with Jardiance, which was approved in August 2014. But developer Boehringer Ingelheim opted to take its EMPA-REG  study a step forward, using a broader sample of patients with type 2 diabetes and an ... Read More

Experimental type 2 diabetes treatment fails in clinical trials

An experimental type 2 diabetes treatment made by Vitae Pharmaceuticals and Boehringer Ingelheim failed to significantly reduce blood sugar levels in patients when used with the first-line medication metformin, and analysts are wary that the medication will provide better results in trials testing it as a monotherapy. The drug was being tested as a treatment for obese patients with type 2 diabetes. The medication, currently known as VTP-34072, would have been the first drug in a class known as 11β-hydroxysteroid dehydrogenase type 1 inhibitor. It was discovered using Vitae’s Contour platform. VTP-34072 works by targeting an enzyme that produces a ... Read More

FDA advisors raise concerns over ‘female Viagra’ during third review

The Food and Drug Administration (FDA), for the third time, is raising concerns about safety risks with the so-called female Viagra drug currently under review. The agency says the drug can cause women to faint and accidentally injure themselves, especially if the medication is taken with alcohol. The concerns were published on the FDA’s website two days before an FDA advisory panel will decide whether to recommend approval of the drug or, for the third time, reject it based on concerns. The FDA is not required to follow the recommendations of its advisory panels, but it usually does. The drug ... Read More

FDA orders post-market studies on newly approved type 2 diabetes drug Jardiance

Jardiance (empagliflozin), a new type 2 diabetes drug, has been granted approval by the U.S. Food and Drug Administration (FDA). The medication can be used alone or added to existing treatment regimens to control blood sugar levels. Jardiance, made by Boehringer Ingelheim, is in a class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors. These drugs work by stopping blood sugar from becoming reabsorbed by the kidneys. Thus, more glucose is excreted by the kidneys, which lowers blood sugar levels. Other SGLT2 drugs include Invokana (canagliflozin) and Farxiga (dapagliflozin). The FDA approved Jardiance based on a review of seven ... Read More

Did Boehringer Ingelheim withhold safety information about blood thinner Pradaxa?

When Pradaxa (dabigatran) hit the market in 2010 to prevent strokes in patients with atrial fibrillation, it became the first alternative treatment to the long-used warfarin for patients with the condition. What made Pradaxa so attractive compared to warfarin (Coumadin) is that patients taking Pradaxa did not have to have their blood monitored on a regular basis in order to prevent potentially deadly bleeding events. However, a British Medical Journal investigation has found that Boehringer Ingelheim, maker of Pradaxa, withheld information that showed patients taking Pradaxa who underwent routine drug level monitoring and dose adjustment could cut bleeding risk by ... Read More

European drug regulators approve new type 2 diabetes treatment

European drug regulators have approved Eli Lilly and Boehringer Ingelheim’s new Type 2 diabetes drug epagliflozin, which will be marketed under the brand name Jardiance. The once-daily tablet is designed to reduce blood sugar levels by blocking glucose reabsorption in the kidneys and remove excess glucose through the urine. Unlike other diabetes treatments, Jardiance does not rely on a patient’s insulin levels in order to be effective. Jardiance is in a class of Type 2 diabetes drugs known as sodium glucose co-transporter 2 (SGLT-2) inhibitors. Other drugs in this class include Canagliflozin, which was the first in the class to ... Read More

Boehringer Ingelheim to pay $650 million to resolve Pradaxa lawsuits

Boehringer Ingelheim announced it will pay $650 million to resolve about 4,000 state and federal lawsuits alleging the company’s blood thinner Pradaxa caused patients to suffer serious bleeding events. Boehringer Ingelheim denied any wrongdoing and said the settlement is being offered to avoid lengthy litigation. The drug company said it expects most, if not all, the plaintiffs to accept the terms of the settlement, and it will vigorously defend itself against those who do not. Pradaxa (dabigatran) was the first drug to be approved from a new class of blood thinners. The drug has been plagued with reports of excessive ... Read More

New diabetes drug gets positive review from European drug advisors

An advisory committee for the European drug authority is recommending the approval of empagliflozin, a new type 2 diabetes drug made by Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin is in a new class of diabetes drugs known as sodium glucose co-transporter 2, or SGLT-2, inhibitors. It works by targeting glucose directly and works independently of B-cell function and insulin resistance. The drug produces increased urinary glucose excretion, with a consequent lowering of plasma, glucose levels, and weight loss. If approved, the empagliflozin would be marketed under the name Jardiance. Earlier this month, the U.S. Food and Drug Administration ... Read More

FDA approves new type 2 diabetes medication Farxiga

A new drug has been approved by the Food and Drug Administration (FDA) to help regulate blood sugar in patients with type 2 diabetes. Farxiga, developed by AstraZeneca and Bristol-Myers Squibb, has been available in Europe under the name Forxiga. U.S. drug regulators rejected the drug last year because of bladder cancer, heart disease and liver toxicity concerns. Farxiga is the second in a class of drugs known as SGLT2 inhibitors to be approved in the United States. Johnson & Johnson’s Invokana was approved earlier this year. Other drugmakers, including Boehringer Ingelheim, are also developing SGLT2 inhibitors. Drugs in this class ... Read More

Boehringer Ingelheim fined for bad faith conduct in Pradaxa lawsuits

Pradaxa

German drug company Boehringer Ingelheim was fined nearly $1 million for failing to preserve and produce critical documents in a multidistrict litigation over its blood thinner Pradaxa when the company knew it was facing numerous product liability lawsuits. Company executives were also ordered to be immediately available for depositions in New York or another convenient location for plaintiffs’ counsel. U.S. District Judge David R. Herndon noted that the court has had to referee disputes in the case related to lost, accidentally destroyed or recently discovered evidence, and found these discovery abuses amounted to bad faith conduct. Discovery documents and communications ... Read More