Regulatory Affairs

Amryt secures funding approval from NHS England for bad cholesterol treatment

PBR Staff Writer Published 10 July 2018

Biopharmaceutical firm Amryt has secured approval for funding from NHS England for its bad cholesterol treatment, Lojuxta (lomitapide).

Lojuxta has received approval for funding as an NHS treatment for adult patients with Homozygous Familial Hypercholesterolaemia (HoFH) in England.

The first in class medicine can reduce the production and uptake of low density lipoprotein (LDL) cholesterol, frequently referred to as bad cholesterol, when used as an adjunctive therapy to other lipid lowering medications.

Amryt said the clinical value of Lojuxta in managing adult HoFH was showed in clinical trials and real world.

From the fourth quarter of this year, Amryt is planning to provide Lojuxta to HoFH patients treated by NHS England.

Lojuxta was approved to treat adult patients with the rare cholesterol disorder, HoFH.

The disorder is said to impair the body's ability to remove LDL cholesterol from the blood, which may lead to abnormally high blood LDL cholesterol levels in the body from before birth.

Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without LDL apheresis in adult patients with HoFH.

 Amryt has an exclusive licence to market Lojuxta European Economic Area, Middle East and North Africa, Switzerland, Turkey, Israel, Russia, the Commonwealth of Independent States and the non-EU Balkan states.

 Amryt Pharma CEO Joe Wiley said: "We are delighted that NHS England has recognised the significant unmet need in the current treatment of HoFH in England and the potential Lojuxta has to significantly improve the lives of HoFH patients.

“Lojuxta has been shown to be an effective adjunctive treatment for adult HoFH patients and has enabled many patients to achieve the recommended target levels of cholesterol for the first time, even stopping apheresis in some cases.”

Amryt is engaged in the development and commercialization of novel treatments for patients with rare or orphan diseases.

Amryt's drug candidate, AP101, is currently in phase 3 clinical trials. It is believed to be a potential treatment for Epidermolysis Bullosa (EB), which is a rare and distressing genetic skin disorder that affects young children.


Image: NHS England headquarters. Photo: courtesy of Lad 2011.