Allergan and its partners at Gedeon Richter have aced the second Phase III study of ulipristal acetate for uterine fibroids, setting up an FDA application in the second half of this year.
Like the first VENUS study, the second aced all the co-primary and secondary endpoints, with significantly improved rates of an absence of bleeding for both the 10 mg and 5 mg arms — 54.8% and 42% — compared to none of the patients in the placebo arm.
The researchers posted similar kinds of improvements for the first and second courses of therapy as well as improvements in the quality of life for the patients taking the therapy. And that sets up an H2 application designed to expand its portfolio of women’s health therapies.
Analysts have been cautiously enthusiastic about Allergan’s new drug, noting that the FDA wants to limit its use to two cycles of treatment. It’s already available in Europe and Canada as Esmya. But the US market could go a long way to pushing this drug to Allergan’s forecast of $500 million to $1 billion in sales — though the consensus figure hovers around the bottom rung of that ladder.
“It is indeed very encouraging that we have another successful phase III study conducted in patients with uterine fibroid symptoms, which shows that ulipristal acetate could bring promising treatment for women suffering from this condition,” added Dr. István Greiner, the research director of Gedeon Richter Plc. “We remain committed to the development of female healthcare products aiming towards the improvement of the quality of life of women in all age groups.”
— Brent Saunders (@brentlsaunders) January 17, 2017
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