AMAG Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the US 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. 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.