FDA Decision Anticipated on sNDA filing in the Fourth Quarter 2017
WALTHAM, Mass., April 17, 2017 (GLOBE NEWSWIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the Makena® subcutaneous auto-injector, a drug-device combination product. The current Makena intramuscular (IM) injection is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.
In October 2016, the company initiated a definitive pharmacokinetic (PK) study which AMAG believes demonstrated comparable bioavailability between the subcutaneous auto-injector product and the current IM injection form of Makena in 120 healthy post-menopausal women. Notably, Makena administered subcutaneously via the auto-injector demonstrated bioequivalence for area under the curve (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL for the IM injection), a key PK parameter, with the 90 percent confidence interval for the ratio of AUC (105.17 to 124.39) falling within the 80 to 125 percent range.
“The Makena auto-injector has the potential to meet the needs of providers by offering the convenience of a ready-to-administer subcutaneous auto-injector while at the same time providing patients with an alternative option to an IM injection,” said Julie Krop, MD, chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. “We look forward to working with the FDA to help bring this drug-device combination product to market as a demonstration of our commitment to advancing treatment options for the patients and providers we serve.”
AMAG recently conducted a survey of treatment preferences of the administration of Makena via subcutaneous auto-injector compared to IM administration among 183 women, including some women who are currently receiving, or previously received, IM hydroxyprogesterone caproate (HPC) injections, or who are eligible to receive future therapy based on their obstetric history.1 The analysis indicated that based on product descriptions, patients would prefer the Makena subcutaneous auto-injector due to the decreased time needed to administer the injection, the shorter needle and the lack of visibility of the needle during the injection process. Further, it showed that the women also perceived these attributes, particularly the limited visibility of a subcutaneous needle, as important drivers of adherence to the therapeutic regimen. These data were included in the sNDA submission.
AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. AMAG developed the Makena auto-injector with its device partner Antares Pharma, Inc., (NASDAQ:ATRS) which holds issued patents on the auto-injector. If the Makena auto-injector is approved, AMAG will request Orange Book listing of the eligible Antares patents, the last of which expires in 2026.
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.
About Makena® (hydroxyprogesterone caproate injection) Intramuscular Injection
Makena® is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.
The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure. Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
For additional product information, including full prescribing information, please visit www.makena.com.
This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, among others, AMAG’s beliefs about the study data, including that the PK study demonstrate comparable bioavailability between the subcutaneous auto-injector and the current IM injections and that the PK study demonstrated bioequivalence on a key PK parameter of area under the curve; beliefs that the area under the curve measurement is a key PK parameter for this study; beliefs that the auto-injector has the potential to meet the needs of providers by offering the convenience of a ready-to-administer subcutaneous auto-injector while providing patients with an alternative option to an IM injection; AMAG’s ability to bring the drug-device combination product to market; expectations regarding the approval timeline of the supplemental new drug application for the Makena auto-injector product and the timing of launch of the Makena auto-injector; beliefs about whether women will prefer the Makena subcutaneous auto-injector and whether certain attributes of the auto-injector will drive greater adherence to the therapeutic regimen; the ability to list eligible auto-injector patents in the Orange Book, 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 risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions 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® is a registered trademark of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. CBR® is a registered trademark of CBR Systems, Inc.
1 Study conducted by Trinity Healthcare (sponsored by AMAG Pharmaceuticals, Inc.)
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AMAG Pharmaceuticals, Inc.