CAMBRIDGE, MA, USA I May 31, 2013 I Aegerion Pharmaceuticals, Inc. (AEGR), a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion with a unanimous vote recommending a marketing authorization for LOJUXTA(TM) (lomitapide) hard capsules. If approved, LOJUXTA will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH).
The European Commission (EC) needs to ratify the positive opinion from CHMP to grant marketing authorization for LOJUXTA in all 27 European Union member countries. A decision is expected from the European Commission in the third quarter of 2013.
“The positive CHMP opinion for LOJUXTA marks a significant milestone for patients in the EU with HoFH who currently have limited treatment options available that can bring their LDL-C levels to goal,” said Marc D. Beer, Chief Executive Officer of Aegerion. “We will continue to prepare for commercial launch in the EU on a country-by-country basis, and look forward to delivering this important new medicine to patients in need in the EU.”
HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing low-density lipoprotein cholesterol (LDL-C or “bad” cholesterol) from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
Conference Call Details
Aegerion will hold a conference call to provide a business update on Monday, June 3, 2013 at 8:30 a.m. EDT. In addition, the Company will answer questions concerning business developments and trends, and other matters affecting the Company, some of the responses to which may contain information that has not been previously disclosed.
To listen to the conference call, dial (866) 516-3002 (international callers dial (760) 298-5082). In addition, the presentation will be webcast live, and may be accessed for up to 30 days following the call, by visiting the “Investors” section of Aegerion’s website, www.aegerion.com.
About Aegerion Pharmaceuticals
Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal, rare diseases. For more information about the company, please visit www.aegerion.com.
SOURCE: Aegerion Pharmaceuticals
Post Views: 91
CAMBRIDGE, MA, USA I May 31, 2013 I Aegerion Pharmaceuticals, Inc. (AEGR), a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion with a unanimous vote recommending a marketing authorization for LOJUXTA(TM) (lomitapide) hard capsules. If approved, LOJUXTA will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH).
The European Commission (EC) needs to ratify the positive opinion from CHMP to grant marketing authorization for LOJUXTA in all 27 European Union member countries. A decision is expected from the European Commission in the third quarter of 2013.
“The positive CHMP opinion for LOJUXTA marks a significant milestone for patients in the EU with HoFH who currently have limited treatment options available that can bring their LDL-C levels to goal,” said Marc D. Beer, Chief Executive Officer of Aegerion. “We will continue to prepare for commercial launch in the EU on a country-by-country basis, and look forward to delivering this important new medicine to patients in need in the EU.”
HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing low-density lipoprotein cholesterol (LDL-C or “bad” cholesterol) from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.
Conference Call Details
Aegerion will hold a conference call to provide a business update on Monday, June 3, 2013 at 8:30 a.m. EDT. In addition, the Company will answer questions concerning business developments and trends, and other matters affecting the Company, some of the responses to which may contain information that has not been previously disclosed.
To listen to the conference call, dial (866) 516-3002 (international callers dial (760) 298-5082). In addition, the presentation will be webcast live, and may be accessed for up to 30 days following the call, by visiting the “Investors” section of Aegerion’s website, www.aegerion.com.
About Aegerion Pharmaceuticals
Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal, rare diseases. For more information about the company, please visit www.aegerion.com.
SOURCE: Aegerion Pharmaceuticals
Post Views: 91
