Amgen Receives Marketing Approval for Cholesterol Drug Repatha

The FDA has approved marketing of Amgen’s PCSK9 cholesterol drug, Repatha (evolocumab). The drug has been approved for patients who are unresponsive to maximally tolerated doses of statins.

Amgen announced the drug will be priced at $14,100 a year; a figure that is $1.36 less per day compared to rival drug Praluent. Praluent (alirocumab) was developed by Sanofi and Regeneron, and was the first PCSK9 drug to be approved by the FDA.

Barclays analyst Geoff Meacham comments, “With limited differentiation between the Praluent and Repatha labels, and close to parity pricing, we expect both entrants to focus on growing the overall class utilization versus a reliance on short-term contracting wins, ahead of cardiovascular outcomes data before [year’s end 2017]. Either way, we continue to expect payers to aggressively manage utilization.”

A number of studies conducted by both Amgen and the Sanofi/Regeneron collaboration, demonstrated the positive effect both drugs had on reducing bad cholesterol, potentially benefitting those at risk of cardiovascular disease. Thousands of participants were involved in each trial.

The drugs are being marketed to patients who don’t see improvements in cholesterol levels following the use of statins. Market analysts are saying that Sanofi/Regeneron and Amgen have positioned themselves well in preparation for talks to begin with key payers. These payers will be negotiating discounts on the PCSK9 cholesterol drugs, which will ultimately decide which company gains market share.

“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” said the executive vice president of Global Commercial Operations at Amgen, Anthony C. Hooper.

“We are confident in the ability of Repatha to demonstrate real-world effectiveness and value based on intensive LDL cholesterol reductions, and we will be working with payers and other purchasers to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions, and anticipated appropriate patient utilization. By partnering with payers to implement these programs, we can help ensure that all appropriate patients who could benefit from Repatha will have access to this important new therapy.”

Two other pharmaceutical companies, Pfizer and Esperion, have their own cholesterol drug in the works, which would add some additional competition to the market. Pfizer is developing a PCSK9 inhibitor, while Esperion’s LDL-lowering drug is expected to receive approval following completion of an upcoming Phase III clinical trial.

Sources:

• Amgen gets a big win with FDA OK for PCSK9 cholesterol drug Repatha – http://www.fiercebiotech.com/story/amgen-gets-big-win-fda-ok-pcsk9-drug-repatha/2015-08-27?utm_medium=rss&utm_source=feedly&utm_campaign=rss