April 12, 2018 Source: finance.yahoo 141
The FDA extends the review period of NDA for AbbVie (ABBV) and partner Neurocrine Biosciences' endometriosis candidate, elagolix, by three months to third-quarter 2018.
AbbVie Inc. ABBV and partner Neurocrine Biosciences announced that the FDA has extended the review period of marketing application for the companies’ pipeline candidate, elagolix, by three months. As a result, the regulatory body will now announce its decision by the third quarter of 2018 instead of the previously anticipated second-quarter 2018 timeline.
AbbVie is looking to get elagolix approved as an oral medicine for pain management associated with endometriosis.
Last September, the FDA accepted AbbVie's new drug application (NDA) for elagolix and subsequently, granted priority review status in October. However, the regulatory body requested for an extended time frame to review additional information, provided by AbbVie along with its NDA pertaining to liver function test results.
Notably, management showed confidence in the company’s data provided to the FDA and continues to work with the regulatory body to bring elagolix to the U.S. market.
We remind investors that the NDA filing was supported by positive results from two replicate pivotal phase III trials, evaluating elagolix for the aforementioned indication. The detailed data from the study, presented last October, showed that treatment with elagolix resulted in statistically significant reductions in menstrual and non-menstrual pelvic pain associated with endometriosis compared with placebo.
Data from the studies also demonstrated superiority as compared to placebo in alleviating pelvic pain, non-menstrual pelvic pain and painful intercourse associated with endometriosis.
Endometriosis affects an estimated one in 10 women of reproductive age and is associated with pain symptoms. At present, there is no cure for the disease. The pain associated with it is currently managed with oral contraceptives, progestins, danazol, NSAIDS, opioids and GnRH agonists. Many medicines are not specifically indicated for treating endometriosis. If approved, elagolix will be the first option for patients in need of an additional treatment to apprehend the disease.
AbbVie’s share price has surged 45.4% in a year, comparing favorably with the industry’s 7.5% gain.
Meanwhile, Elagolix is also being evaluated in two phase III programs for preventing heavy menstrual bleeding in premenopausal women with uterine fibroids.
Importantly, another pharma company Allergan AGN also has a pipeline candidate, ulipristal acetate, in its portfolio, which is currently under evaluation for treatment of uterine fibroids. Here too, the FDA in February requested to extend the review period of the company’s NDA for the candidate to August 2018.
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