PHARMACY

Takeda’s investigational diabetes drug helps reduce HbA1C levels

BY Allison Cerra

DEERFIELD, Ill. — An investigational diabetes therapy made by Takeda helped lower HbA1C levels among patients with Type 2 diabetes, the drug maker said.

The mid-stage clinical trial, which included 426 patients, showed TAK-875, a selective agonist of GPR40 — one of the orphan G-protein-coupled receptors expressed in pancreatic islet cells — demonstrated its ability to stimulate insulin in a glucose-dependent manner over a 12-week period, with minimum risk of hypoglycemia. Patients were either given doses ranging from 6.25-mg to 200-mg a day or 4-mg of placebo glimepiride.

"As glucose control in many patients with Type 2 diabetes continues to remain suboptimal, it is important to work to identify new mechanisms of action in an effort to improve treatment options," said Thomas Strack, development therapeutic area head of metabolic at Takeda. "Because of its observed ability to potently stimulate insulin secretion and improve glycemic control with less or no hypoglycemia, these data further support TAK-875 as a potential therapy for the treatment of Type 2 diabetes in the future."

These data were presented at the American Diabetes Association 71st Annual Scientific Sessions and published in The Lancet. The drug now is moving forward into phase-3 clinical development.


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PHARMACY

Endo integrates business units, plans name change

BY Alaric DeArment

CHADDS FORD, Pa. — Endo’s parent company is looking to change its name and will integrate four of its operating units, the drug maker said Thursday.

Endo said the company, currently called Endo Pharmaceutical Holdings, would ask shareholders to approve changing the name to Endo Health Solutions at its annual shareholder meeting in May.

Endo also aggregated AMS, its medical device unit; Endo Pharmaceuticals, its branded drug unit; HealthTronics, its medical services unit; and Qualitest, its generic drugs unit. The company said the four would share "visual and verbal identity standards" with that of the parent company.

"With the right organizations in place, we have modernized our four distinct operating companies into an enterprise that reflects a powerful combination of compatible organizations aimed at delivering fully integrated healthcare solutions for the benefit of physicians, payers and patients," Endo president and CEO Dave Holveck said. "We are excited to be setting a new standard for healthcare solutions delivery."


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American Diabetes Association responds to FDA’s warning on safety of statins

BY Allison Cerra

ALEXANDRIA, Va. — The American Diabetes Association said it is urging people with diabetes who currently are taking a statin to continue their medication unless instructed otherwise by their healthcare provider.

ADA’s statement followed an announcement from the Food and Drug Administration on Tuesday, in which the agency said safety changes would be put into effect for the labeling of several cholesterol-lowering drugs. The FDA said Tuesday that the drugs may cause increases in blood sugar and other symptoms: "Increases in blood-sugar levels (hyperglycemia) have been reported with statin use," the agency said. "The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with Type 2 diabetes mellitus."

"Every drug has its risks and benefits, and with statins the risk is small and can be managed," said Vivian Fonseca, president of medicine and science at the American Diabetes Association. "On the other hand, people with diabetes, can receive great benefit from taking these medications. They’ve been proven to prevent heart attacks and prolong life."

The American Diabetes Association noted that it "continues to support the FDA in its role as the regulatory agency that makes decisions regarding drug safety and efficacy."


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