Drugmaker AMAG Pharmaceuticals ($AMAG) said it reached key development milestones for two of its pipeline drugs: the subcutaneous autoinjector version of Makena and the anemia drug Feraheme.
For Makena, the first patient in the definitive pharmacokinetic study and comparative pain study received a dose of the company’s subcutaneous autoinjector program (Makena SQ). Makena is an FDA-approved treatment used to reduce the risk of preterm birth in women who are pregnant with one baby and who have delivered one preterm baby spontaneously in the past.
A healthcare provider administers a weekly injection of Makena starting as early as week 16 of the pregnancy up until week 37 or the baby is born, whichever occurs first.
“The Makena subcutaneous autoinjector is designed for easier administration by healthcare providers and potentially less painful injections for patients, and we are focused on completing the development of this product and bringing it to market as quickly as possible,” AMAG CEO William Heiden said in a statement.
Enrollment of patients in the Phase III label-expansion trial of Feraheme, which is designed to treat iron-deficiency anemia, surpassed the two-thirds mark toward the total enrollment of 2,000 patients. The news is a sign that AMAG is picking up momentum and is now looking at filing a supplemental new drug application by the middle of next year.
“With an earlier [supplemental new drug application] filing for Feraheme, we hope to receive FDA approval for a broader label sooner than previously forecasted, which if approved, could significantly expand the number of patients who could benefit from Feraheme therapy in the future,” Heiden said.
AMAG picked up Makena in 2014 when it acquired KV Pharmaceuticals, which had changed its name to Lumara Health following bankruptcy, for $1.25 billion. When KV launched the drug at $1,500 per dose, patient groups--and eventually politicians--raised an outcry over the pricing.
Feraheme is FDA approved to treat iron-deficiency anemia in patients with chronic kidney disease. AMAG had hoped for a new, broader use for the drug in other iron-deficiency anemia patients, but the FDA thwarted those plans in January 2014 and began looking into adverse event reports on the drug as European regulators added safety warnings to Feraheme's EU label.