Amgen and Sanofi/Regeneron Pharmaceuticals may be locked in one of the most intriguing US drug regulatory races of recent memory, but it is the European Medicines Agency that has provided a first definitive regulatory action for the PCSK9 inhibitor class by recommending approval of Amgen's Repatha.
The EMA has recommended approval of a broad label for Repatha in Europe, which includes those patients with mixed dyslipidaemia who are unable to reach LDL-cholesterol reduction goals with statin therapy or whom are intolerant to statins. Furthermore, Phase III data for Repatha has demonstrated LDL-C reductions of 46 percent to 64 percent from baseline at week 12 in various patient populations with hyperlipidaemia.
How cardiologists utilise this drug class is, however, a very different matter. Data from ongoing outcomes studies – due to be published in 2017/18 – are expected to shape the longer-term uptake of the PCSK9 inhibitors, while other factors – such as pricing and access – will also play a prominent role on the European landscape (ViewPoints: Europe provides positive regulatory momentum for PCSK9 inhibitor class, but regional cardiologists likely to prescribe less than US counterparts).
Reasons to Purchase
To better ascertain sentiment towards the PCSK9 inhibitor class, FirstWord Pharma is asking cardiologists based in France, Germany, Italy, Spain and the UK the following questions...
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