Allergan says ‘safety concerns’ prompted US FDA rejection

23-Aug-2018 - Last updated on 23-Aug-2018 at 15:17 GMT

(Image: Getty/sarawuth702)

The US FDA has vetoed Allergan’s ulipristal acetate candidate, designed for the treatment of abnormal uterine bleeding in women with uterine fibroids.

Ulipristal acetate is a selective progesterone receptor modulator (SPRM), which targets the progesterone receptors in the endometrium (uterine lining), uterine fibroids, and the pituitary gland.

The product is marketed by Gedeon Richter in Europe, under the name Esmya, and by Allergan in Canada, under the trade name Fibrastal. Esmya and Fibristal are approved for the pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

According to Allergan, the agency cited safety concerns regarding Esyma post-marketing reports outside the US in the complete response letter (CRL), and has requested additional information.

“We intend to meet with the FDA to discuss the CRL and determine the potential next steps for our ulipristal acetate new drug application,” said Allergan’s chief research and development officer, David Nicholson, in a statement.

In May this year, reports of serious liver injury in women taking Esmya raised regulatory concern. Following a review of the women’s health drug, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee concluded: “Esmya may have contributed to the development of some cases of serious liver injury”.

At the time, the EMA recommended, “several measures be put in place to minimise the risk of rare but serous liver injury with Esmya (ulipristal acetate). Certain women may start treatment with Esmya once the new measures are implemented.”

Contraindication in women with known liver problems, and liver tests before, during and after stopping treatment, were among the measures cited.

An Allergan concern?

The CRL comes almost three months after Allergan acknowledged its women’s health business – to which ulipristal acetate belongs – is not counted among its four key therapeutic areas.

Following a strategic review, CEO Brent Saunders said the firm planned to “look and see if there are ways to create value by selling our infectious disease or women’s health business."

“That process has been initiated,” he added, at Bernstein’s thirty-fourth annual strategic decisions conference on May 31, 2018. The firm is yet to announce a sale.