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
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
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
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
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Source: AMAG Pharmaceuticals, Inc.