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Allergan plans to file oral uterine fibroid drug in US by year-end

Analysts predict treatment will reach blockbuster sales as phase III trials meet objectives

AllerganThere is good news for the millions of women worldwide who suffer from uterine fibroids, after an oral therapy hit its objectives in a second phase III trial.

The studies of Allergan and Gedeon Richter's ulipristal acetate showed that the drug was able to reduce abnormal bleeding caused by uterine fibroids - also known as myomas - which can cause a catalogue of symptoms including pain, urinary and bowel dysfunction and reduced fertility.

In the VENUS II study, significantly more patients who were dosed with ulipristal 10mg (54.8%) and 5mg (42.0%) achieved absence of bleeding, with all patients in the placebo group continuing to suffer bleeding episodes over the course of the 12-week study period. Those results are in line with the earlier VENUS I trial, according to the two companies.

With two positive pivotal trials in hand, Allergan says it is on course to file for FDA approval of ulipristal acetate in the second half of 2017, and analysts at Credit Suisse have suggested that worldwide sales potential could be around $1.25bn by 2020.

Ulipristal has been on the market in a different formulation - as an emergency contraceptive - since 2009 in Europe and 2010 in the US. In 2012 the drug was cleared by the EMA for pre-operative treatment of moderate to severe symptoms of uterine fibroids, with its indications extended to include intermittent use in the long-term management of the condition in January last year.

The company estimates that up to 80% of women in the US develop uterine fibroids by the age of 50, with the incidence highest among African-American women.

Treatment in the US is currently carried out by injections with gonadotropin-releasing hormone analogues such as AbbVie's Lupron (leuprolide acetate) - which provide limited relief – along with minimally-invasive procedures such as laparoscopic removal of fibroids or more drastic surgeries such as hysterectomy.

"We are confident that the results of our phase III trials for ulipristal acetate may potentially offer the first and only oral treatment option for women suffering from uterine fibroids in the US," said Allergan's R&D chief David Nicholson.

Other companies working on new therapies for uterine fibroids include Bayer, which has a candidate called vilaprisan in mid-stage clinical development.

Article by
Phil Taylor

17th January 2017

From: Research, Regulatory



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