PHARMACY

Study: Metformin best first-line diabetes treatment

BY Allison Cerra

NEW YORK — While several drugs to treat Type 2 diabetes are on the market, researchers have found that the best first-line option is metformin.

Led by Wendy Bennett, an assistant professor of medicine at Johns Hopkins University School of Medicine in Baltimore, researchers reviewed 140 trials and 26 observational studies of head-to-head comparisons of monotherapy or combination therapy that reported intermediate or long-term clinical outcomes or harms of six oral diabetes medications.

Despite the fact that all of the drugs — metformin, second-generation sulfonylureas, thiazolidinediones, meglitinides, dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 receptor agonists — reduced hemoglobin A1C levels as either a monotherapy or combination therapy, metformin proved to be the most efficacious for posing the least amount of risks.

The other treatments, study authors noted, posed a higher risk of such conditions as hypoglycemia, congestive heart failure and bone fractures.

"Metformin continues to be an inexpensive medication, and it’s very efficacious," Bennett said.

The study was published in the Annals of Internal Medicine.

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PHARMACY

Aegerion’s lomitapide granted orphan-drug status by FDA

BY Alaric DeArment

CAMBRIDGE, Mass. — A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

Aegerion Pharmaceuticals announced that it received the designation for lomitapide as a potential treatment for familial chylomicronemia. The drug currently is in phase-3 trials as a treatment for homozygous familial hypercholesterolemia, and Aegerion said it expects to start a separate clinical trial to evaluate the drug for familial chylomicronemia in the second half of this year.

“The FDA’s grant of orphan-drug designation to lomitapide for the treatment of FC represents an important milestone in the overall development and commercialization plan for the compound, and it underscores the unmet need that exists,” Aegerion CEO Marc Beer said. “With this announcement, we are another step closer toward our goal of [treating] patients with these rare lipid disorders that currently have inadequate treatment options available.”

The FDA gives orphan-drug designation to treatments for diseases that affect fewer than 200,000 people in the United States. The designation includes tax incentives, possible exemption from the FDA user fee and a seven-year market exclusivity period upon approval, compared with the usual five years.

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SXC’s CEO named chairman of the board

BY Alaric DeArment

LISLE, Ill. — Pharmacy benefit manager SXC Health Solutions has appointed president and CEO Mark Thierer as chairman of the board, the company said.

Thierer previously was a director at the company and replaces Terrence Burke, who will retire from the company this year. Board compensation committee chairman Steve Cosler has been appointed lead independent director for the company.

“On behalf of the board and management at SXC, I’d like to thank Terry for [more than] 10 years of leadership and support as a director of SXC,” Thierer said. “During the past several years, we have made significant strategic moves to establish SXC as the industry’s leading middle-market PBM, and we are well positioned to maintain our momentum and continue along our aggressive growth trajectory.”

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