AMAG PHARMACEUTICALS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FILING FOR BREMELANOTIDE
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bremelanotide, a first-in-class melanocortin 4 receptor agonist designed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the bremelanotide NDA is March 23, 2019.
HSDD is the most common type of female sexual dysfunction, affecting approximately six million premenopausal women in the U.S. HSDD is characterized by persistent low sexual desire (or libido) that is associated with distress, often negatively impacting women’s emotional health, intimate relationships, and overall quality of life.
“Women who experience diminished sexual desire report feeling like something is missing and experience distress as a result. They want to get their desire back but may not think to attribute its loss to a medical condition that can be treated,” said Dr. Julie Krop, chief medical officer and executive vice president of medical development and regulatory affairs at AMAG. “AMAG is dedicated to further raising awareness of this common condition and offering patients and clinicians an innovative treatment option that can be given as desired rather than daily, due to its unique mechanism of action.”
Functional magnetic resonance images (fMRI) of women with and without HSDD who were exposed to visual sexual stimuli has demonstrated less activation in the areas of the brain associated with sexual interest and arousal in women with HSDD.1 Bremelanotide, which is designed to be used in anticipation of a sexual encounter, has a novel mechanism of action that impacts the balance between inhibitory and excitatory neural pathways in the brain to restore sexual desire.
In its acceptance letter, the FDA stated that it is planning to hold an advisory committee meeting to discuss this application. If approved, this new treatment will be available as a self-administered, disposable subcutaneous auto-injector to be used in anticipation of a sexual encounter.
Bremelanotide is a new chemical entity (NCE) that has been studied in more than 30 clinical trials with over 2,500 women. AMAG’s NDA submission was supported by clinical data from two large double-blind placebo-controlled Phase 3 studies in which bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient-reported outcomes.
The most common adverse events were nausea, flushing and headache. The majority of events were reported to be transient and mild-to-moderate in intensity.
“Coupled with our recent regulatory successes for Makena® (hydroxyprogesterone caproate) and Feraheme® (ferumoxytol), this acceptance marks another important milestone in our efforts to develop and bring to market new therapies that help address unmet medical needs,” said William Heiden, president and chief executive officer at AMAG. “Today AMAG has a strong commercial presence in the women’s health space, and we look forward to leveraging that footprint, along with our deep relationships with the healthcare professional community, to support our launch of bremelanotide, if approved in early 2019.”
AMAG in-licensed bremelanotide from Palatin Technologies, Inc. in February 2017. The FDA’s acceptance of the NDA triggers a $20 million milestone payment to Palatin, less agreed upon deductions for expenses incurred by AMAG.
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD is the most common type of female sexual dysfunction affecting an estimated six million pre-menopausal women in the United States. The condition is characterized by low sexual desire and marked distress which are not attributable to existing medical, pharmacologic, psychiatric, or relationship issues. It is thought to result from an imbalance in certain chemicals in the brain that affect sexual excitation or inhibition. Patient awareness and understanding of this condition remains low, and few women currently seek or receive treatment. Recent industry-sponsored market research indicates that up to 95 percent of premenopausal women suffering from low desire with associated distress are unaware that their condition is HSDD, a treatable medical condition.
About Bremelanotide and the Phase 3 RECONNECT Studies
Bremelanotide, an investigational product, is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
The Phase 3 RECONNECT studies for HSDD in premenopausal women consisted of two double-blind placebo-controlled, randomized parallel group studies comparing as desired use of 1.75 mg of bremelanotide versus placebo, in each case, delivered via a subcutaneous auto-injector. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24-week evaluation period. In both clinical trials, bremelanotide met the pre-specified co-primary efficacy endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.
Women in the trials had the option, after completion of the trial, to continue in an open-label safety extension study for an additional 52 weeks. Nearly 80% of patients who completed the randomized portion of the study elected to remain in the open-label portion of the study.
In the Phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in intensity and transient.
AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of maternal and women’s health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the expected indication of bremelanotide, if approved; AMAG’s belief that it has a strong commercial presence in the women’s health space and its intentions to leverage that footprint, along with its deep relationships with the healthcare professional community, to support the launch of bremelanotide, if approved, in 2019; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, those identified in AMAG’s Securities and Exchange Commission (SEC) filings, including AMAG’s Annual Report on Form 10-K for the year ended December 31, 2017, Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals®, Makena® and Feraheme® are registered trademarks of AMAG Pharmaceuticals, Inc. CBR® is a registered trademark of Cbr Systems, Inc.
AMAG Pharmaceuticals, Inc. Contacts:
Linda Lennox 908-627-3424 1 Bianchi-Demicheli, Francesco et al. (2011) "Neural Bases of Hypoactive Sexual Desire Disorder in Women: An Event-Related fMRI Study"Journal of Sexual Medicine; 2546–2559.