Amgen Files NDA For I.V. Rival To Sensipar
This article was originally published in The Pink Sheet Daily
The calcimimetic etelcalcetide could be administered intravenously following dialysis sessions for chronic kidney disease patients with secondary hyperparathyroidism, eliminating the high pill burden associated with Sensipar.
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FDA issued a complete response letter for the Sensipar follow-on, and Amgen declined to provide any details about the reason why or timeline for resubmission.
Amgen will get KAI’s late-stage-ready asset for a small upfront price and gives itself a logical line extension to its chronic kidney disease drug Sensipar.
Pfizer expects Comirnaty and Paxlovid revenues to be drastically lower this year after pushing 2022 revenues over $100bn. Management said 2023 would be a transition year for the company.