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news.The US Food and Drug Administration (FDA) has accepted Crinetics Pharmaceuticals' paltusotine new drug application (NDA) as a long-term maintenance and potential treatment for acromegaly in the adult population.
The NDA for paltusotine includes data from Phase III trials. Credit: Trnava University on Unsplash.
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Acromegaly is a serious disease which is generally caused by a benign pituitary adenoma.
Paltusotine would be the first, once-daily, oral selective somatostatin receptor type 2 nonpeptide agonist for adults with this condition if it is approved.
The NDA was supported by data from the Phase III trials, PATHFNDR-1 and PATHFNDR-2, which assessed the efficacy and safety of the therapy in both previously treated and medically untreated adult subjects, respectively.
The FDA has set a target action date of 25 September next year to complete the review of the NDA.
An advisory committee meeting is not expected as part of the application’s review process.
In July 2020, the therapy received orphan drug designation for the same indication from the US regulator.
Crinetics Pharmaceuticals CEO and founder Scott Struthers said: “With our patient-centred clinical development of paltusotine, we were guided by an unwavering ambition to deliver a new generation of treatment that provides a once-daily, oral alternative to the currently marketed peptide analog drugs.
“We look forward to working with the FDA throughout the review of our new drug application, as we also prepare for a potential commercial launch by building out our infrastructure and engaging with payers and the endocrinology community.”
Paltusotine is the company’s lead candidate and has completed Phase III clinical development for the given indication.
The company is also initiating Phase III trial for carcinoid syndrome associated with neuroendocrine tumours. The therapy is designed to provide a once-daily oral treatment option for the control of acromegaly and symptoms related to carcinoid syndrome.
In Phase III studies, paltusotine maintained insulin-like growth factor-1 (IGF-1) levels and symptom control in individuals with acromegaly who switched from monthly injectable medications, as seen in PATHFNDR-1.
