Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced that Japan's Ministry of Health, Labor & Welfare (MHLW) has approved pricing of Juxtapid in Japan. The pricing authorization follows Japanese regulatory approval of Juxtapid for the treatment of homozygous familial hypercholesterolemia (HoFH) on September 28, 2016.

HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C (bad cholesterol) from the body. A loss of LDL receptor function results in extreme evaluation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.

"The pricing authorization is the last major step before making this important therapy available to patients in Japan," said Mary Szela, chief executive officer of Aegerion. "Juxtapid plays a valuable clinical role in HoFH, helping patients reduce and sustain reductions in LDL-C. We're pleased that the pricing reflects the value of this therapy and allows the company to expand the company's global reach in serving patients with rare diseases."

In Japan, HoFH is recognized as an intractable disease, which is defined by the lack of established treatment and the significant risk to patients. The company looks forward to working with Japanese healthcare providers to serve those patients who have been identified through the intractable disease program while supporting the identification of patients who remain undiagnosed and at risk.

Because of the importance of maintaining a low-fat diet and taking nutritional supplements for patients on Juxtapid, Aegerion has provided specific guidance on these items to physicians.

The safety and effectiveness of Juxtapid has not been established in patients with hypercholesterolemia who do not have HoFH, or in pediatric patients. The effect of Juxtapid on cardiovascular morbidity and mortality has not been determined.