FDA approves first PCSK9 inhibitor

Praluent is the first-approved PCSK9 inhibitor in the US.
Praluent is the first-approved PCSK9 inhibitor in the US.

The FDA on Friday approved Sanofi's and Regeneron's Praluent, making it the first PCSK9 inhibitor to come to market in the US. It is part of a new touted class of cholesterol-lowering drugs.

PCSK9 inhibitors are antibodies that deactivate a specific protein in the liver, which dramatically lowers levels of bad, or LDL, cholesterol.

Praluent was approved for use in patients with heterozygous familial hypercholesterolemia, a genetic disorder that causes unusually high levels of bad cholesterol in the blood. The injectable drug also received an indication for use in patients with heart disease who require additional lowering of cholesterol beyond what statins can provide. The total market for the drug is an estimated eight to 10 million people in the US.

Sanofi and Regeneron plan to target both primary care providers and cardiologists, using a “large, dedicated field force,” Susan Barrett, Regeneron's executive director of Praluent marketing, and Victoria Carey, Sanofi's global vice president and US head for Praluent, said in an email.

The wholesale acquisition cost, which excludes discounts, is $14,600 per year, according to Sanofi. The companies are defending the price, saying that it “reflects the potential that it can provide to individual patients with uncontrolled elevated LDL cholesterol, and its overall total value to the healthcare system.”

Amgen, too, is developing a PCSK9 inhibitor that is expected to receive a decision from the FDA on August 27. Sanofi had exchanged a priority-review voucher in order to receive a hastened approval time for Praluent, granting the drugmaker a review a month prior to Amgen's PDUFA date.

An FDA advisory panel ruled 13-3 in June in favor of recommending Praluent for approval and then ruled 11-4 in favor of Amgen's Repatha the following day.

Intouch Solutions and MicroMass are two of the agencies tapped to develop the campaign for the PCSK9 inhibitor, according to MM&M's 2015 Agency Issue

Entrée Health executives noted that their agency is working on the payer-access strategy for Amgen's Repatha. 

The company executives declined to provide details about the campaign but they said they plan to use a broad range of channels to educate healthcare providers.

This story has been updated. 

MM&M's coverage of the emerging PCSK9 market, so far: