AMAG Pharmaceuticals : Files Submission in Response to the Food and Drug Administration's Notice of Opportunity for a Hearing and Proposal to Withdraw Approval of Makena

WALTHAM - AMAG Pharmaceuticals, Inc. has submitted its response to the FDA's Notice of Opportunity for a Hearing ('NOOH') regarding the Agency's proposal to withdraw approval for Makena-also referred to as 17-OHPC-the only FDA-approved treatment, along with five generic versions, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

The submission of supporting documentation follows upon AMAG's October 14, 2020 request for a hearing and provides detail on the company's position in requesting a hearing, recognizing clinicians' decade-long use of this treatment and the public health implications of withdrawing approval. The response sets out data, analyses, and information demonstrating why Makena should remain available as the only FDA-approved option for women in the U.S. who are at risk for preterm birth, including clinical study results that highlights the evidence of effectiveness of Makena among Black and other minority women.

AMAG-and its new owner, Covis Pharma Group, a leading pharmaceutical company that has a track record of working collaboratively with FDA and is focused on providing therapeutic solutions for patients with life-threatening conditions and chronic illnesses-stand ready to discuss data-driven next steps to maintain Makena as an option for physicians and patients, including developing a new randomized, controlled trial and further evaluating real-world data.

'We seek a hearing to ensure that higher risk women and their doctors retain access to the only safe and effective, FDA-approved treatment for preterm birth and remain committed to the science and clinical experience supporting the value of Makena for appropriate U.S. patients,' said Covis CEO Michael Porter. 'We stand ready to work collaboratively with the Agency to address methods of more fully understanding and maintaining this important treatment option for this high-risk underrepresented, principally minority patient population. Preterm birth is an increasing health issue in the U.S., with preterm birth rates significantly higher than in other developed countries. We believe that a thorough review of the benefits of Makena, particularly among at-risk, disadvantaged communities, is required.'

Nearly a year after the divided Advisory Committee meeting and without an opportunity to discuss options for further data generation, FDA sent a NOOH to AMAG and generic manufacturers of 17-OHPC. At the Advisory Committee meeting, experts agreed that additional data would be useful in clarifying benefit or defining the population in whom the drug may provide the most benefit. AMAG agrees that additional data would be helpful and had hoped to discuss several possible avenues with FDA.

AMAG, and its new owner Covis, remain committed to conducting a further study of 17-OHPC. As described in the submission response, possible additional studies include: (1) a retrospective study using secondary real-world data sources, including electronic health record databases and claims databases and (2) a prospective, primary data collection study with selected hospitals and healthcare networks, such as the Maternal-Fetal Medicine Units Network as well as non-academic sites. AMAG is also open to discussing another randomized clinical trial, better focused on the most at-risk, principally minority patient populations.

A summary of key arguments that warrant discussion at a public forum can be found in the full copy of the submission available here. While the FDA reviews the submission of supporting documentation, Makena remains approved and available and the product label remains unchanged.

About AMAG

AMAG is a commercial-stage biopharmaceutical 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.

About Covis

Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses.

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