Amgen has a new tool to employ in its battle with Sanofi and Regeneron for PCSK9 market dominance. The drugmaker said today that the FDA has approved a new hands-free injector for a once-monthly dose of the drug that it expects to have on the market within weeks.
Amgen ($AMGN) said the FDA approved its Pushtronex, an on-body infusor with a prefilled cartridge, to give a single monthly dose. The device will carry the WAC price of $14,100 annually, the same as the twice-weekly product, the Thousand Oaks, CA-based company said in its announcement.
When Repatha was first approved by the FDA in August 2015, the dosing was 140 mg every two weeks or 420 mg once monthly. Until the approval of the single-dosing option, the 420-mg monthly dose required three 140-mg injections to be administered consecutively within 30 minutes.
“Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration," the company said in its announcement.
Amgen’s Repatha and Sanofi ($SNY) and Regeneron's ($REGN) Praluent are scrapping for every bit of leverage for their new drugs, which block a protein that inhibits the body's natural system to eliminate "bad" cholesterol. When they were near approval last year, analysts had very high expectations, believing they would be used along with the inexpensive generic statins that millions of people currently take for lowering cholesterol, or at least for those who can’t tolerate statins.
But the FDA stopped short of designating them for that indication. Instead, they're approved for patients with a hereditary form of high cholesterol, and those at high risk of heart problems who haven't responded to aggressive statin therapy.
That gave payers the defense they needed to limit use of the drugs, whose annual cost is way beyond that of cheap generic statins. Instead of allowing doctors carte blanche authority to prescribe them, payers are requiring them and their patients to go through a document-intensive preapproval process.
Those difficulties have kept sales low so far. Analysts have forecast that both drugs could generate about $3 billion in annual sales by 2022. Repatha was forecast to have about $185 million in sales this year and Praluent as much as $265 million, yet in the first quarter both turned in only about $20 million.
- here’s the announcement
NICE gives tentative broad approval to both Repatha, Praluent
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