WALTHAM -
The submission of supporting documentation follows upon AMAG's
AMAG-and its new owner,
'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
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
Contact:
Tel: 617.498.3300
Fax: 617.649.1654
Email: contactus@amagpharma.com
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