FDA rejects Mercks cholesterol drug, Cordaptive
Merck has received a not approvable action letter from the FDA for its new drug application (NDA) for MK-0524A (ER niacin/laropiprant), branded as Cordaptive, for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, PhD, executive vice president and president of Merck Research Laboratories.
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Kim.
Despite its recent setbacks, Merck reaffirmed the 2008 financial guidance it issued last week and said it's still confident it will meet its goal of double-digit annual growth in adjusted earnings per share through 2010.
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, PhD, executive vice president and president of Merck Research Laboratories.
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Kim.
Despite its recent setbacks, Merck reaffirmed the 2008 financial guidance it issued last week and said it's still confident it will meet its goal of double-digit annual growth in adjusted earnings per share through 2010.