FDA Pushes Back PDUFA Date for AbbVie’s Endometriosis Drug

Published: Apr 11, 2018 By

Review Time

The U.S. Food and Drug Administration wants more time to review AbbVie’s elagolix, a treatment for endometriosis-associated pain.

On Monday AbbVie and its developmental partner Neurocrine Biosciences, Inc. announced the FDA pushed back its PDUFA review time by three months.

The news sent shares of Neurocrine down about 4 percent on Monday to $75.48. That companies stock rallied back a bit to close at $77.50. Shares of AbbVie dipped slightly on Monday to $92.77 before closing at $94.01.

The FDA said it requires more time to review additional information regarding the results of liver function tests that were submitted along with the New Drug Application (NDA). The FDA is now set to make a decision in the third quarter of this year, AbbVie announced on Monday. In October the FDA granted priority review for elagolix, with an expectation that it would have a PDUFA in the second quarter of this year. If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade. Analysts predict that elagolix could generate more than $1 billion in annual revenue by 2022, BioPharma Dive reported.

Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms.

Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. AbbVie is studying elagolix in multiple indications that are mediated by ovarian sex hormones, such as uterine fibroids and endometriosis. So far elagolix has been involved in more than 40 clinical trials totaling more than 3,000 subjects, AbbVie said.

AbbVie’s NDA for elagolix was filed in September 2017 and was supported by data from two replicate Phase III studies that showed that, at month three and month six, once daily doses of elagolix at 150 mg twice daily 200 mg doses resulted in a statistically significant higher proportion of responders for menstrual pain (dysmenorrhea) and non-menstrual pelvic pain associated with endometriosis. Data showed that elagolix significantly reduced the three types of endometriosis-associated pain – daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse, according to AbbVie.

While the FDA’s decision to push back the timeline for its ruling on elagolix was a setback for AbbVie and Neurocrine, the companies remain confident in the data submitted to the regulatory agency. Michael Severino, AbbVie’s chief scientific officer, reaffirmed that feeling of confidence in the NDA for elagolix.

“Elagolix has the potential to be an important new treatment option for women suffering from endometriosis and we are committed to working with the FDA to bring this therapy to patients,” he said in a statement.

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