NICE Recommends Vazkepa and Evrenzo
The UK’s National Institute for Health and Care Excellence (NICE) has recommended National Health Service (NHS) use of Amarin’s Vazkepa (icosapent ethyl) for the reduction of heart attacks or strokes in adults who have controlled low-density lipoprotein cholesterol (LDL-C) and are taking a statin but have raised levels of triglycerides.
Vazkepa (icosapent ethyl)
The endorsement for Vazkepa was based on clinical trial data that showed the oral drug reduced the risk of cardiovascular events by more than 25 percent compared with placebo.
Evrenzo (roxadustat)
NICE also recommended Astellas Pharma and FibroGen’s oral drug Evrenzo (roxadustat) for treatment of adult patients with symptomatic anemia associated with chronic kidney disease who are at stages 3 to 5 with no iron deficiency and aren’t on dialysis at the start of treatment.
The negotiated NHS price for Vazkepa is $179 for a 30-day supply. The negotiated price for Evrenzo was not disclosed.
About Vazkepa
Vascepa capsules are the first prescription treatment approved by the US Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid. Vascepa was launched in the United States in January 2020 as the first and only drug approved by the US FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. Since launch, Vascepa has been prescribed over 18 million times. Vascepa is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, Germany and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name Vazkepa. In April 2021 marketing authorization for Vazkepa (icosapent ethyl) was granted in Great Britain. The Great Britain Marketing Authorization for Vazkepa applies to England, Scotland and Wales.
Roxadustat is the first orally administered Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor available in the EU. It increases haemoglobin (Hb) levels through a different mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs) which are typically co-administered with intravenous (IV) iron. As a HIF-PH inhibitor, roxadustat activates the body’s natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, co-ordinated processes that allow management of anaemia with a reduced use of IV iron.
June 13, 2022
