Amgen's PCSK9 Inhibitor Gets FDA Nod For Stroke Prevention

Amgen, Inc. (NASDAQ:AMGN) announced that the FDA has approved its regulatory application seeking approval to include data from the cardiovascular outcomes study, FOURIER, on the label of its PCSK9 inhibitor, Repatha.

With the label expansion, Repatha can now be prescribed to prevent heart attacks, strokes and coronary revascularizations in patients with established cardiovascular disease.

This year so far, Amgen’s shares are up 21.2%, better than 2.6% increase registered by the industry.

Data from the phase IIIFOURIER study, presented in the first quarter, had revealed significant reduction in myocardial infarctions and strokes on treatment with Repatha compared with the current best therapy alone.

Repatha significantly reduced risk of hard MACE (heart attack, stroke or cardiovascular death) by 20% compared to the standard treatment with statin therapy. For individual components, risks of heart attack, stroke and coronary revascularization were nominally reduced by 27%, 21% and 22%, respectively, with Repatha.

However, Repatha did not show any improvement in cardiovascular death risk, which had raised investor concerns then.

Notably, Repatha gained an FDA approval in August 2015, for the treatment of patients, incapable of managing their LDL cholesterol at acceptable levels. It is approved in over 50 countries, including the United States, Japan, Canada and overall, 28 member countries of the European Union for the given indication.

However, uptake of the drug has not been very encouraging so far due to higher pricing and re-imbursement issues/payer restrictions. Sanofi (NYSE:SNY) and partner Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) also faced similar issues with their PCSK9 inhibitor, Praluent.

The FOURIER data holds the key to the commercial success of Repatha as it will broaden the use of the drug. With the cardiovascular indication approved to be included in Repatha’s label, patient access to the drug should improve.

Amgen filed regulatory applications in both the United States and EU to include FOURIER data on Repatha’s label in June 2017. In July, the FDA had granted priority review forthe regulatory application.

Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked large-cap pharma stock is Johnson & Johnson (NYSE:JNJ) , which has a Zacks Rank #2 (Buy).

Shares of J&J have risen 21.5% this year so far while 2018 earnings estimates have gone up 0.7% in the past 60 days.

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