AMAG gets second FDA approval in two weeks

FDA approved an sNDA from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) for subcutaneous Makena hydroxyprogesterone caproate injection to reduce the risk of preterm birth in women who spontaneously delivered one preterm baby in the past. AMAG jumped $4.05 (29%) to $17.95 and partner Antares Pharma Inc. (NASDAQ:ATRS) added $0.37 (19%) to $2.35 on the news.

AMAG plans to launch subcutaneous Makena in the second half of March. Its wholesale acquisition cost (WAC) will be $803 per mL, the same as the intramuscular formulation of Makena approved by FDA in 2011, according to AMAG spokesperson Sarah Connor.

Last week, FDA approved an sNDA from AMAG to expand the label of Feraheme ferumoxytol to treat iron deficiency anemia (IDA) in adults with intolerance or insufficient response to oral iron.

Makena is a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P) that uses Antares' QuickShot device. Feraheme, an IV iron replacement therapy, is already marketed in the U.S. to treat IDA in adults with chronic kidney disease (CKD).