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Amgen's (AMGN) Repatha Gains EU Nod to Include Outcomes Data

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Biotech major Amgen Inc. AMGN gained approval from the European Commission (EC) for its regulatory application seeking approval to include data from the cardiovascular outcomes study, FOURIER, on the European label of its PCSK9 inhibitor, Repatha.

With the label expansion application, Repatha gets approval to prevent heart attacks, strokes and coronary revascularizations by lowering LDL-C or “bad” cholesterol levels in adults with established atherosclerotic cardiovascular disease in Europe. Though Amgen’s shares have declined 0.1% so far this year, it is still better than the 10.2% decrease registered by the industry.

The FOURIER outcomes data is already included in the U.S. label of Repatha, following FDA approval in December last year.

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

Repatha significantly reduced the 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 reduced by 27%, 21% and 22%, respectively.

Uptake of Repatha, which gained FDA approval in August 2015, has not been encouraging so far due to pricing and re-imbursement issues/payer restrictions. Sanofi SNY and partner Regeneron Pharmaceuticals, Inc. REGN also faced similar issues with their PCSK9 inhibitor, Praluent. The priority for Amgen right now is to improve patient access to Repatha.

The outcomes data (FOURIER) is the key to the commercial success of Repatha as it would broaden the use of the drug. With the cardiovascular indication approved to be included in Repatha’s label, patient access to Repatha is expected to improve. In fact, in the first quarter of 2018, Repatha generated revenues of $123 million compared with $98 million in the previous quarter driven by volume growth. On the call, management said that access to Repatha for high risk cardiovascular patients has improved over the past few months with the FOURIER outcomes data included on the Repatha label. With the data now also approved to be included in the European label of Repatha, we expect sales to increase further as patient access to the medicine improves.

Amgen said it is working with European payers to remove prescribing barriers, improve Repatha’s affordability and expand access to the drug.

Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked biotech stock is Ligand Pharmaceuticals Incorporated LGND with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ligand’s earnings per share estimates increased 4.2% for 2018 and 0.4% for 2019 in the last 30 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 31.79%. The company’s shares have rallied 41.1% year to date.

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