FDA approves new Boehringer Ingelheim and Eli Lilly alliance type 2 diabetes treatment.
The Food and Drug Administration (FDA) has approved Jentadueto XR, a new extended release form of the combination medication Jentadueto. Produced by Boehringer Ingelheim and Eli Lilly & Co., Jentadueto XR is a medication for treating type 2 diabetes.
Jentadueto, originally approved by the FDA in January 2012, is a once per day combination of linagliptin and metformin hydrochloride. The new Jentadueto XR is a combination of linagliptin and extended release metformin hydrochloride. The XR is derived from ‘extended release’.
Extended release metformin is a more expensive drug than standard release metformin but has the benefit of milder side effects. Metformin commonly causes digestive discomfort. Usually this passes after a few weeks taking the medication, but for some people the problem can be severe or persistent. Extended release metformin is recommended for people that struggle to cope with the side effects of standard metformin.
Jentadueto XR will be suitable only in cases where the patient could be treated with metformin and linagliptin individually, and should be used as part of management treatment that includes diet and exercise. Linagliptin, when not used as a component of a combination drug, is marketed under the name Tradjenta.
“Adults with type 2 diabetes are often required to take more than one medication to manage their condition, including some that have to be taken multiple times a day,” said the CEO of Boehringer Ingelheim, Paul Fonteyne.
“Jentadueto XR, the first extended-release therapy to emerge from our alliance with Lilly, offers adults with type 2 diabetes the convenience of a combination pill taken once a day to help lower blood sugar levels.”
Linagliptin works by affecting hormone levels after meals. It stimulates insulin production after meals while decreasing levels of glucagon. Insulin is the hormone that lowers blood glucose levels and glucagon is the hormone that raises glucose levels.
Jentadueto XR is not to be used to treat type 1 diabetes, nor diabetic ketoacidosis. It has not been studied for suitability in people with diabetes and pancreatitis. Jentadueto XR carries a boxed warning of a risk of lactic acidosis, a very rare but serious complication that affects some people that take metformin.
A statement from the alliance of the two pharmaceutical companies stated that the drug was found to be safe and efficient based on “adequate and well-controlled studies of linagliptin and metformin co-administered in patients with type 2 diabetes inadequately controlled on diet and exercise.”
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