Type of information: Submission of an sNDA
Product name: Makena® subcutaneous auto-injector
Compound: hydroxyprogesterone caproate injection
Therapeutic area: Women health - Fertility
Action mechanism: Makena® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Company: Amag Pharmaceuticals (USA - MA)
Disease: reduction of the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past
- • On April 17, 2017, Amag Pharmaceuticals announced that it has submitted a supplemental new drug application (sNDA) to the FDA for the Makena® subcutaneous auto-injector, a drug-device combination product. The current Makena® intramuscular injection is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.
- In October 2016, the company initiated a definitive pharmacokinetic study which Amag believes demonstrated comparable bioavailability between the subcutaneous auto-injector product and the current IM injection form of Makena in 120 healthy post-menopausal women. Notably, Makena® administered subcutaneously via the auto-injector demonstrated bioequivalence for area under the curve (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL for the IM injection), with the 90 percent confidence interval for the ratio of AUC (105.17 to 124.39) falling within the 80 to 125 percent range.
- Amag recently conducted a survey of treatment preferences of the administration of Makena® via subcutaneous auto-injector compared to IM administration among 183 women, including some women who are currently receiving, or previously received, IM hydroxyprogesterone caproate (HPC) injections, or who are eligible to receive future therapy based on their obstetric history. The analysis indicated that based on product descriptions, patients would prefer the Makena® subcutaneous auto-injector due to the decreased time needed to administer the injection, the shorter needle and the lack of visibility of the needle during the injection process. Further, it showed that the women also perceived these attributes, particularly the limited visibility of a subcutaneous needle, as important drivers of adherence to the therapeutic regimen. These data were included in the sNDA submission.
- Amg anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. Amag developed the Makena® auto-injector with its device partner Antares Pharma which holds issued patents on the auto-injector. If the Makena® auto-injector is approved, Amag will request Orange Book listing of the eligible Antares patents, the last of which expires in 2026.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
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Orphan status UE:
Pediatric exclusivit _USA:
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