Dive Brief:
- Waltham, MA-based Amag Pharmaceuticals is moving ahead with development plans for its two best-selling drugs, announcing Wednesday that supplemental new drug applications for broader labels of Makena and Feraheme are both on track to be filed with the Food and Drug Administration next year.
- The first patient in a pharmacokinetic study of a subcutaneous form of the progestin Makena (hydroxyprogesterone caproate injection) has been dosed, Amag said. Development of the subcutaneous auto-injector could help fend off competition from compounders.
- Amag also touted higher enrollment levels in its Feraheme (ferumoxyl) Phase 3 label expansion trial, aimed at treatment iron deficiency anemia (IDA). The increased enrollment has accelerated the anticipated sNDA filing date into mid-2017. Feraheme is currently indicated to treat kidney disease.
Dive Insight:
Makena has been a key drug for Amag since it picked up the drug through a 2014 purchase of Lumara Health.
The company reported increased net product sales of Makena of $143 million over the first six months of the year, compared to $119 million during the same time period a year prior. Sales growth in the most recent quarter was driven by an increase in volume as more at-risk pregnant women were treated with Makena, the company said.
Amag is hoping to add to those sales. In May, the company launched its single-dose, preservation free formula of Makena, aimed to stave off competition from the compounded segment of the market. With anticipated regulatory review of the subtaneous injector, the company anticipates eventually further expansion.
“Makena is the primary driver of AMAG’s business and the subcutaneous formulation of Makena could provide strong protection from direct competition for the period through 2025 or 2026,” wrote SmithOnStocks analyst Larry Smith of Makena. “
AMAG plans to file the sNDA for the Makena SQ auto-injector in the second quarter of 2017 and anticipates a decision on approval as early as first quarter of 2018.
Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult CKD patients and was commercially launched by AMAG in the U.S. shortly thereafter. Approximately 4.5 million Americans suffer from IDA and many IDA patients fail treatment with oral iron due to intolerability or side effects.
The company hopes with an earlier sNDA filing, it “could significantly expand the number of patients who could benefit from Feraheme therapy in the future,” Heiden said. Two years ago, the FDA had rejected an application to expand Feraheme’s CKD label to include adult iron deficiency anemia.