PregLem announces positivie phase III results from Esmya

PEARL I trial meets primary efficacy and safety endpoints

04-Jun-2010 - Switzerland

PregLem announced positive Phase III data from its second pivotal study (PEARL I) for its lead product Esmya (ulipristal acetate), as an effective treatment for uterine fibroids (myoma).

The final set of positive Phase III results, combined with the positive PEARL II results announced in May 2010, will enable PregLem to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by the end of 2010. Upon approval, PregLem expects to launch the product in major European markets.

PEARL I was designed to demonstrate superior efficacy of Esmya versus placebo for the treatment of symptomatic uterine fibroids in women with heavy bleeding leading to anaemia. It was a randomised, parallel group, double-blind, placebo-controlled, multi-centre study with a total of 242 patients. It compared 5mg and 10mg doses of Esmya and placebo once daily for three months with concomitant iron administration in all three arms.

The study met its two co-primary efficacy endpoints. Esmya demonstrated statistically significant superior efficacy to placebo in reducing excessive uterine bleeding measured as a percentage of patients with a reduction of PBAC (Pictorial Blood Assessment Chart) score lower than 75 and in reduction of total fibroids volume assessed by centralised MRI reading.

Esmya also showed superior efficacy to placebo in correcting anaemia caused by uterine fibroids and suppressing fibroids-related pain using the McGill Short Form questionnaire (SF-MPQ). Both the PBAC and SF-MPQ are validated self-reporting tools.

https://www.bionity.com/en/news/118537/preglem-announces-positivie-phase-iii-results-from-esmya.html