We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Amgen's PCSK9 Inhibitor Gets FDA Nod for Stroke Prevention
Read MoreHide Full Article
Amgen, Inc. (AMGN - Free Report) 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 (SNY - Free Report) and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) 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.
A better-ranked large-cap pharma stock is Johnson & Johnson (JNJ - Free Report) , 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.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
Image: Bigstock
Amgen's PCSK9 Inhibitor Gets FDA Nod for Stroke Prevention
Amgen, Inc. (AMGN - Free Report) 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 (SNY - Free Report) and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) 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 (JNJ - Free Report) , 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.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
Click here for Zacks' private trades >>