Aegerion’s lomitapide granted orphan-drug status by FDA
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.
SXC’s CEO named chairman of the board
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.”
Pradaxa added to CVS Caremark’s, Medco’s commercial preferred drug lists
RIDGEFIELD, Conn. — A drug used to prevent stroke in patients with a form of atrial fibrillation has won preferred Tier 2 formulary status with pharmacy benefit managers Medco Health Solutions and CVS Caremark.
Boehringer Ingelheim Pharmaceuticals announced Monday that CVS Caremark and Medco had added Pradaxa (dabigatran etexilate mesylate) capsules to their commercial preferred drug lists, and Medco had added the drug to its Part D drug list.
“These formulary additions will offer nonvalvular atrial fibrillation patients increased access to Pradaxa, including its demonstrated ability to significantly reduce the risk of stroke over warfarin in this patient population,” Boehringer Ingelheim Pharmaceuticals VP cardiovascular and metabolic disorders marketing Wa’el Hashad said. “We look forward to a long relationship with CVS Caremark and Medco, and are committed to working with other pharmacy benefit managers, as well as offering our own programs to help make Pradaxa available to patients with nonvalvular atrial fibrillation.”