WALTHAM, Mass. October 25, 2019 – AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the results of PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) were published online in the American Journal of Perinatology. PROLONG was a randomized, double-blind, placebo-controlled clinical trial evaluating 17-OPHC (17-α-hydroxyprogesterone caproate or Makena®) in patients with a history of a prior spontaneous singleton preterm delivery. The PROLONG trial was conducted as part of an approval commitment under the Food & Drug Administration’s (FDA) “Subpart H” accelerated approval process.
As previously announced, the PROLONG trial did not meet the two pre-specified co-primary endpoints of a reduction of preterm birth (defined as less than 35 weeks of gestation) and a reduction in the neonatal morbidity and mortality index, in contrast to the original Meis trial results published in the New England Journal of Medicine. PROLONG reaffirmed that the 17-OHPC safety profile is comparable to placebo.
The FDA will hold a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) on October 29, 2019, to better understand and interpret the PROLONG trial data.
About Makena® (hydroxyprogesterone caproate 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. Makena was approved by the FDA in February 2011 and was granted orphan drug exclusivity through February 3, 2018. In February of 2018, AMAG introduced the prefilled Makena auto-injector containing a short, thin, non-visible needle for subcutaneous use, offering patients and providers a new administration option.
Makena has certain limitations 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.
For additional product information, including full prescribing information, please visit www.makena.com.
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking information about AMAG 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, the perceived relationship between the Meis trial and PROLONG trial; and how the FDA will interpret the PROLONG data 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, the risk that the Makena franchise is currently solely dependent on sales from the Makena auto-injector in light of the company’s exit from the Makena IM market, and the Makena auto-injector may not be successful, including if (i) AMAG is unsuccessful in convincing patients to use or healthcare providers to prescribe the Makena auto-injector product or (ii) the FDA takes adverse action related to Makena in response to the results of the PROLONG study and the FDA’s ongoing review, including following the Advisory Committee meeting scheduled November 29, 2019; as well as 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, 2018, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019 and subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”), which are available at the SEC’s website at www.sec.gov. Any such 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® and the logo are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc.
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