FDA refuses Allergan’s uterine bleeding therapy with a request for more data
pharmafile | August 22, 2018 | News story | Research and Development, Sales and Marketing | Allergan, Esmya, FDA, pharma
Allergan has shared the news that the FDA has refused to award marketing authorisation to its ulipristal acetate product Esmya for the treatment of abnormal uterine bleeding in women with uterine fibroids.
The US regulator issued a complete response letter (CRL) to the pharma firm, citing dissatisfaction over the robustness of supporting data supplied with Allergan’s new drug application (NDA). This issue brought with it safety concerns with Esmya’s use in post-marketing reports outside of the US, and the FDA has requested that Allergan provide additional data to rectify these conerns.
As part of its NDA, Allergan had supplied data derived from two Phase 3 clinical trials in the US, EU registration studies and real-world data harvested from more than 700,000 women living with uterine fibroids across 80 countries.
Allergan confirmed it would meet with the FDA to negotiate a solution to the concerns. The company’s Chief Research and Development Officer David Nicholson commented: “Allergan continues to believe in the need for novel treatment options for women who are looking for a non-surgical treatment for uterine fibroids. We intend to meet with the FDA to discuss the Complete Response Letter and determine the potential next steps for our ulipristal acetate NDA.”
Esmya is a selective progesterone receptor modulator (SPRM) which acts on the tissues of the endometrium (uterine lining), uterine fibroids, and the pituitary gland. The therapy was subjected to temporary restrictions by European regulators after reports surfaced of the drug’s use being linked to serious liver injury; in May, it was concluded that the drug may have contribute din some cases, and recommended measures to mitigate potential risk.
Matt Fellows
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