Lomitapide Should Be Approved for HoFH in Europe, EMA Advised

Disclosures

June 01, 2013

LONDON, UK — The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that the lomitapide preparation Lojuxta (Aegerion Pharmaceuticals) be approved "as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low-density-lipoprotein apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH)"[1]. Such recommendations are usually adopted officially by the EMA.

 

The "positive opinion" rendered by the CHMP follows FDA approval of the same company's lomitapide preparation Juxtapid for the same indication in December 2012, as reported by heartwire . The FDA's advisory panel had recommended its approval by a vote of 13 to 2.

"The benefits with Lojuxta are its ability to consistently reduce LDL-cholesterol levels by approximately 40% in HoFH patients," according to an EMA statement. "The most common side effects are gastrointestinal and hepatic adverse events, [in] some cases leading to treatment discontinuation."

Lomitapide has "orphan-drug" status on both sides of the Atlantic; HoFH occurs in the population at the rate of about one in one million, which would indicate only about 300 cases in the US.

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