The FDA approves second PCSK9 inhibitor, Repatha
The FDA approved Amgen's PCSK9 inhibitor, Repatha, setting up a battle for market share with Sanofi's and Regeneron's Praluent in one of the most hyped new drug classes of 2015.
PCSK9 inhibitors are antibodies that deactivate a specific protein in the liver, which dramatically lowers levels of bad, or LDL, cholesterol.
Amgen won approval to treat patients with homozygous familial hypercholesterolemia (HoFH) and heterozygous familial hypercholesterolemia (HeFH) and in patients with heart disease who need their cholesterol to be lowered beyond what statins can provide. Repatha will also compete for market share with Aegerion's Juxtapid for patients with HoFH.
Amgen will price the drug at $14,100 per year before discounts—a $500 discount compared to Praluent, which will cost $14,600 a year.
The company plans to work closely with payers to implement “innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilization,” Anthony Hooper, Amgen's EVP of global commercial operations, said in a release.
Repatha is expected to be available in the US next week.
Sanofi and Regeneron did not seek approval to treat patients with HoFH. Both Praluent and Repatha are now approved to treat HeFH.
“We plan to leverage this competition to achieve the best possible price for the patients and payers we represent,” Brian Henry, a spokesperson for Express Scripts, said in an email. “These back-to-back approvals should allow natural market competition to influence the ultimate cost for the PCSK9 inhibitors.”
The pharmacy benefit manager plans to review the clinical profile of both drugs in the coming weeks.
An FDA advisory committee voted 11-4 to recommend Repatha for approval in heterozygous familial hypercholesterolemia. Repatha was approved by the European Commission in July.
Intouch Solutions and MicroMass are two of the agencies tapped to develop the campaign for Praluent, according to MM&M's 2015 Agency Issue. Entree Health executives said that the agency is working on the payer-access strategy for Amgen's Repatha.
MM&M's coverage of the emerging PCSK9 market, so far:
- FDA approves first PCSK9 inhibitor (July 24, 2015)
- Praluent's FDA review looms, but questions persist (July 22, 2015)
- Survey shows doctors ready for PCSK9s (June 15, 2015)
- PCSK9 drugs show viability, tolerability (March 16, 2015)
- Specialty medications have PBMs on edge (Feb. 17, 2015)
- Sanofi, Regeneron officially in PCSK9 race (Jan. 16, 2015)