NICE changes mind on Amgen’s cholesterol drug
pharmafile | February 8, 2016 | News story | Manufacturing and Production, Sales and Marketing | Amgen, NICE, Repatha
NICE has changed its mind on Amgen’s cholesterol-busting drug Repatha (evolocumab), and decided to recommend approval of the treatment in a secondary consultation for patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.
Although the second consultation does not represent final guidance, it does mean there is a good chance of the drug being approved this year, after the guidance has again remained open to public consultation. After considering comments received until February 26, the Committee will meet again March 9 and prepare a final appraisal determination (FAD), which will be used as the basis for NICE’s ultimate decision.
NICE rejected the drug in draft guidance published in November, despite strong trial data, on the basis that the application submitted by the company did not include sufficient trial data on cardiovascular outcomes. However, after the secondary consultation, it appears the UK regulator is more inclined to follow European counterparts in recommending the drug, with the caveat that the company must continue to offer a discount as agreed in the patient access scheme.
Amgen welcomed the news, the company’s executive medical director for the UK & Ireland, Tony Patrikios, saying: “NICE has reviewed the technical responses to its initial appraisal, listened to patients and healthcare professionals and proposed a recommendation for the use of Repatha by the NHS in England and Wales.
“However, beyond these draft recommendations, another priority will be patients with existing cardiovascular disease who fail to reduce their LDL cholesterol (LDL-C) to a satisfactory level despite the use of statins and who remain at high risk. For them, access to new treatment options is critically important to help avoid a heart attack or stroke. We will continue to work with NICE to demonstrate the cost-effectiveness of Repatha for such patients, based on the positive progress achieved so far in the appraisal process.”
The positive news for Amgen came at the same time as NICE’s rejection of Sanofi/Regeneron’s own PCSK9 inhibitor, Praluent (alirocumab).
Joel Levy
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