PDUFA day for evolocumab (Repatha) at the US FDA

The first PCSK9 inhibitor approved in the world stands before the FDA today for possible US approval. Evolocumab (brand name is Repatha) was approved by the European Medicines Agency (EMA) May 22, 2015. This novel monoclonal antibody actually blocks the PCSK9 action which would otherwise decrease the number of bad cholesterol (LDL) receptors in the liver and would increase cholesterol. Because of it's blockade on PCSK9, Repatha maintains LDL receptors and works to decrease LDL cholesterol. This is a completely new way of working (mechanism of action) versus the older statin (HMGCoA) medicines such as atorvastatin (Lipitor) or rosuvastatin (Crestor).

While the FDA isn't bound to follow the recommendations of the expert panel, the US experts voted for approval of evolocumab. It can certainly be difficult to predict the actions of the FDA, but it will be interesting to see if the FDA follows the approval pattern (indications) which the EMA granted, or approve for some other indications in the US.

Meanwhile, in Europe, the maker of Repatha reported that it will present 6 abstracts at the ESC congress organized by the European Society of Cardiology. Importantly, a long-term outcomes studey called FOURIER (Further Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) is also under way to evaluate the idea that if evolocumab is used with other treatments for dyslipidemia, decreases in cardiovascular death, heart attack (myocardial infarction), hospitalization for unstable angina, stroke or coronary revascularization will be seen in people (subjects) with clinically evident cardiovascular disease.

Please visit www.clinicaltrials.gov and search identifier NCT01764633 for more information on this research. More to follow as usual once the FDA makes it's announcment.

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