Eagle Pharmaceuticals (NASDAQ:EGRX) announces a clinical development plan to support the submission of a NDA for its fulvestrant formulation.
Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the FDA for the treatment of advanced hormone-related breast cancers.
In March and June 2019, Eagle and FDA, mutually agreed to a clinical program that could provide an efficient approval pathway for the Company’s fulvestrant formulation.
The main goal of the clinical research program is to determine if the unique properties of fulvestrant formulation will result in greater inhibition of estrogen receptors, potentially leading to improved efficacy outcomes, including lower disease progression rates, compared to current treatment options.
Eagle intends to begin a pilot study shortly in healthy female volunteers to evaluate the pharmacokinetics and safety of its novel formulation.
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