An Esperion Therapeutics drug that pairs two cholesterol-lowering medicines in a single pill has been approved by the FDA, the second regulatory nod for the company in less than a week.
The reglator’s decision covers the combination of Esperion’s bempedoic acid (Nexletol) and ezetimibe, an older generic drug for reducing levels of the “bad” form of cholesterol. Last Friday, the agency approved bempedoic acid by itself. Following the Wednesday approval of the combination therapy, shares of Ann Arbor, MI-based Esperion (NASDAQ: [[ticker:ESPR]]) rose more than 2 percent to $58.30 apiece in after-hours trading.
Bempedoic acid, a once-daily pill, was designed to block the synthesis of cholesterol in the liver. That’s a different approach than ezetimibe, which blocks cholesterol absorption in the intestines. Together, the combination is intended to be used in addition to statins, a widely prescribed class of older cholesterol-lowering drug.
Some patients, however, can’t tolerate statin therapy. For others, the drugs don’t enough to help patients reach their cholesterol goals. In a Monday conference call to discuss FDA approval of bempedoic acid, Esperion CEO Tim Mayleben the drug provides a new therapeutic option for patients who need to further lower their cholesterol levels.
Esperion’s combination tablet will be marketed under the name Nexlizet. According to the drug’s label, the most common side effects of the combo drug that were not observed in studies of either bempedoic acid or ezetimibe included urinary tract infections, swelling in the nasal passages and back of the throat, and constipation.
The combo drug’s label also flags the risk of tendon rupture associated with bempedoic acid. This drug-related injury may occur more frequently in patients age 60 or older, and in those who are taking corticosteroids or fluoroquinolone drugs. Tendon rupture is a rare but known risk of fluoroquinolones, a type of antibiotic. The Nexlizet label says patients who have a history of tendon disorder or tendon rupture should avoid the medicine.
Esperion set a March 30 target date for making bempedoic acid commercially available. For those who have insurance, the company has said that a patient’s out-of-pocket cost should be about $10 for a three-month supply. Esperion said Wednesday that when its combination drug becomes available in July, it will be priced the same. The company has scheduled a conference call for Thursday at 8 a.m. Eastern time to discuss the drug’s approval and the plans for its launch.
Image: iStock/ThitareeSarmkasat
