AbbVie Inc. (ABBV) along with partner Neurocrine Biosciences, announced that the phase III study oftheir late stage candidateelagolix met its primary endpoint in women with uterine fibroids. Top-line results from the first of the two pivotal phase III studies on elagolix (ELARIS UF-I) revealed that at six month, elagolix, in combination with low-dose add-back hormone therapy, reduced heavy menstrual bleeding compared to placebo. 68.5% (p<0.001) of women with uterine fibroids achieved clinical response.
The study also met all ranked secondary endpoints at month six.
Hypoestrogenic effects, such as hot flush and reduction in bone mineral density, from elagolix treatment, were observed in the study. However, the overall safety profile for elagolix was consistent with what was observed in phase II studies in uterine fibroids. Data from the phase III study will support regulatory submissions for elagolix and will be presented at an upcoming medical conference.
Elagolix is under review in the United States for the management of endometriosis with associated pain.
So far this year, AbbVie’s shares price have returned 92.1%, comparing favorably with 11.1% gain recorded by the industry.
We note that there are many other companies that have pipeline candidates being evaluated for uterine fibroids. Bayer BAYRY is evaluating vilaprisan in women suffering from uterine fibroids in a phase III ASTEROID study
Allergan’s AGN pipeline candidate, ulipristal acetate’s is under regulatory review in the United States. The company expects the FDA to give its decision in the first half of 2018.
In a separate press release, AbbVie also announced that it has inked anexclusive strategic collaboration and option agreement with a clinical-stage gene therapy company, Voyager Therapeutics VYGR, to develop and commercialize vectorized antibodies for the treatment of Alzheimer’s disease and other neurodegenerative diseases.
Per the deal, Voyager will receive an upfront cash payment of $69 million, as well as up to $155 million in potential preclinical and phase I option payments. Following the announcement of the deal, shares of Voyager rose almost 15%.
Zacks Rank
Abbvie currently carries a Zacks Rank #2 (Buy).
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