AMAG Pharmaceuticals Receives Complete Response Letter From FDA for the Single-Dose Vial of Makena(R) (Hydroxyprogesterone Caproate Injection)
WALTHAM, Mass., May 28, 2015 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG), today announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its manufacturing supplement seeking approval for a single-dose vial of Makena. A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA requested additional information related to manufacturing procedures for the single-dose vial at a new third-party manufacturer. The Company remains committed to commercializing a single-dose vial of Makena and plans to work with the FDA on a timely response.
Makena, the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past, is currently marketed in a multi-dose vial, containing five weekly injections. The FDA’s letter has no impact on the currently marketed version of the product.
“We believe that the approval of a single-dose vial of Makena could provide important added flexibility and efficiency for our customers, with the assurance of a product that meets the FDA’s strict quality requirements for sterile injectables,” said William Heiden, chief executive officer of AMAG. “We continue to plan for a commercial launch of the single-dose vial now in the fourth quarter of 2015. Importantly, we do not anticipate today’s news changing our financial outlook for 2015.”
About Makena® (hydroxyprogesterone caproate injection)
Makena® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy 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 U.S. product information, including full prescribing information, please visit www.makena.com.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on maternal health, the treatment of iron deficiency anemia in patients with chronic kidney disease and cancer supportive care. The primary goal of AMAG is to bring to market therapies that provide clear benefits and improve patients’ lives. In addition to continuing to pursue opportunities to make new advancements in patients’ health and to enhance treatment accessibility, AMAG intends to continue to expand and diversify its portfolio through the in-license or purchase of additional pharmaceutical products or companies, including revenue-generating commercial products and late-stage development assets that leverage the company’s corporate infrastructure, sales force call points and commercial expertise. For additional company information, please visit www.amagpharma.com.
Safe Harbor Statement
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 plans to respond to the FDA, including the expected timeline and review cycle; beliefs about the flexibility and efficiency of the single-dose, preservative-free vial of Makena; expectations for the commercial launch of the single-dose vial; AMAG’s financial outlook and plans to continue to expand and diversify its portfolio; as well as AMAG’s efforts to provide products with clear benefits that improve patients’ lives 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, AMAG’s ability to successfully implement Makena’s lifecycle management program, including to effectively respond to the FDA’s complete response letter by, among other things, providing the additional information requested by the FDA regarding manufacturing procedures and methods used to control the microbiological environment in which the product is produced and the sterilization of equipment used in production; the impact of AMAG’s response to the FDA’s request that AMAG consider changing the color combination on the container label and carton labelling to provide more optimal readability; AMAG’s ability to implement the commercial launch of the new single-dose vials of Makena, including on the anticipated timeline; the impact of perceptions related to pricing and access on Makena’s commercial success and growth prospects; AMAG’s ability to have Makena manufactured in sufficient quantities and at acceptable costs to meet commercial demand and clinical development needs and such other 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 fiscal year ended December 31, 2014 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. Lumara Health™ and Makena® are trademarks of Lumara Health IP Ltd.
CONTACT: Linda Lennox Vice President, Investor Relations & Corporate Communications 617-498-2846
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