FDA Approves Antares Pharma's Hydroxyprogesterone Caproate Injection (Makena) to Reduce Risk of Preterm Birth

Antares Pharma with partner AMAG Pharmaceuticals, announced the US Food and Drug Administration (FDA) approval of the hydroxyprogesterone caproate injection (Makena) subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment reducing the risk of preterm birth in pregnant women with 1 baby who spontaneously delivered 1 preterm baby in the past.

The drug-device combination product utilizes the Antares Pharma QuickShot device which was specifically designed to deliver a rapid injection of highly viscous drug products like progesterone in oil, through a fine gauge nonvisible needle.

The prefilled Makena auto-injector offers a new administration option for both patients and providers, containing a shorter and thinner non-visible needled as opposed to the intramuscular Makena injection.

“The consequences of preterm birth are a significant public health issue, and Makena has served an important medical need for appropriate at-risk pregnant mothers over the past several years,” Sean Blackwell, MD, chair of the department of obstetrics, gynecology and reproductive sciences, University of Texas Medical School, president of the Society for Maternal-Fetal Medicine, said in a statement. “The Makena subcutaneous auto-injector offers healthcare providers an important alternative mode of delivery for patients at risk of recurrent preterm birth.”

Makena, first approved by the FDA in February 2011, remains the first and only FDA-approved treatment option currently available for pregnant women who had a prior spontaneous preterm birth.

The injector’s effectiveness 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 like improvement in neonatal mortality and morbidity.

AMAG Pharmaceuticals excepts the subcutaneous auto-injector to be available in the second half of March, offering Makena in both single-dose and multi-dose vials.

"This drug-device combination product, which features a smaller, non-visible needle, was designed to address some of the known barriers to treatment of recurrent preterm birth, including lack of patient acceptance and adherence," Julie Krop, MD, chief medical officer and executive vice president of clinical development and regulatory affairs, AMAG, said.

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