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Amgen's Repatha Gains CHMP Nod to Include Outcomes Data
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Biotech major Amgen Inc. (AMGN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive recommendation to 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, Amgen is looking to get Repatha approved to prevent heart attacks, strokes and coronary revascularizations in adults with established atherosclerotic cardiovascular disease in Europe.
Though Amgen’s shares have declined 1.8% so far this year, it is still better than the 5.7% 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 III FOURIER study presented last year 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 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 - Free Report) and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) 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.
However, some analysts believe that though data from the study looks good, it is not very clear if payers will be willing to improve access to Repatha based on this data.
In a separate press release, Amgen and partner Allergan announced that the CHMP has also given a positive opinion recommending marketing authorization for ABP 980, their biosimilar version of Roche’s cancer drug, Herceptin. Amgen/Allergan are looking to get ABP 980 approved in the EU for the same cancer indications as the reference product, including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
The companies’ application to get biosimilar Herceptin approved in the United States is under review with a decision from the FDA expected in May.
Meanwhile, Amgen and Allergan’s Mvasi, a biosimilar version of Roche’s another cancer drug Avastin, was approved in the United States in September last year and in the EU early this year.
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Amgen's Repatha Gains CHMP Nod to Include Outcomes Data
Biotech major Amgen Inc. (AMGN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive recommendation to 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, Amgen is looking to get Repatha approved to prevent heart attacks, strokes and coronary revascularizations in adults with established atherosclerotic cardiovascular disease in Europe.
Though Amgen’s shares have declined 1.8% so far this year, it is still better than the 5.7% 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 III FOURIER study presented last year 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 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 - Free Report) and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) 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.
However, some analysts believe that though data from the study looks good, it is not very clear if payers will be willing to improve access to Repatha based on this data.
In a separate press release, Amgen and partner Allergan announced that the CHMP has also given a positive opinion recommending marketing authorization for ABP 980, their biosimilar version of Roche’s cancer drug, Herceptin. Amgen/Allergan are looking to get ABP 980 approved in the EU for the same cancer indications as the reference product, including HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
The companies’ application to get biosimilar Herceptin approved in the United States is under review with a decision from the FDA expected in May.
Meanwhile, Amgen and Allergan’s Mvasi, a biosimilar version of Roche’s another cancer drug Avastin, was approved in the United States in September last year and in the EU early this year.
Amgen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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