FDA and EMA approve heart drug Praluent
pharmafile | July 27, 2015 | News story | Sales and Marketing | EMA, FDA, PCSK9, Regeneron, Sanofi, high cholesterol, praluent
The FDA and the EMA have both approved Sanofi and Regeneron’s new high cholesterol drug Praluent.
Regulators on both sides of the Atlantic have recommended Praluent, making it the second in a new class of drugs for people with uncontrolled high cholesterol. Earlier in July Praluent’s competitor, Amgen’s Repatha (evolocumab), earned sign-off from the European Commission, but Repatha is yet to be approved in the US.
This makes Praluent the only drug in this class, called PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors, to be approved in the US. Praluent is available in both the US and Europe in doses of 75 mg and 150 mg. In Europe, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending Praluent for use in certain adult patients with hypercholesterolemia.
Praluent and Repatha are for adults with heterozygous familial hypercholesterolemia, in addition to diet and maximally tolerated statin therapy. It is also designated for high-risk cardiovascular disease patients who do not achieve sufficient cholesterol reduction benefit from statin therapy alone to lower their risk of heart problems.
The approval of Praluent is based on data from the pivotal Phase III ODYSSEY program, which showed consistent, positive results compared to placebo and current standard of care therapy with statins.
Olivier Brandicourt, chief executive at Sanofi, says: “Despite significant progress over the last decades, high cholesterol remains a leading concern in the US and globally. Praluent demonstrates the power of the Sanofi and Regeneron alliance to deliver a first-in-class therapy in the US for patients in need. Sanofi has a strong cardiovascular heritage and dedication to these patients, and we look forward to working with other regulatory authorities to make Praluent available to patients worldwide.”
Following its approval in Europe, Elias Zerhouni, president of global R&D at Sanofi, says: “We are very pleased to receive a positive opinion from the CHMP for Praluent, and look forward to bringing Praluent to those in greatest need across Europe. Despite statins and other lipid-lowering therapies, many patients are unable to reach their LDL cholesterol goals, and may benefit from new therapeutic options such as Praluent.”
The European Commission is expected to make a final decision on the marketing authorisation application for Praluent in the European Union in late September.
In the US Sanofi and Regeneron say they will be pricing Praluent at $40 per day, or $1,120 every 28 days – a total of$14,600 per year.
Yasmita Kumar
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