US FDA approves Makena injection using ‘smaller, non-visible needle’ tech

By Flora Southey

- Last updated on GMT


Related tags Childbirth

AMAG has received approval for its preterm birth risk reduction product combining the drug product supplied by Pfizer and Antares Pharma’s auto-injection system.

AMAG Pharmaceuticals announced last week that the US Food and Drug Administration (FDA) approved its subcutaneous, prefilled auto-injector combination version of Makena, developed in collaboration with device partner Antares Pharma.

The FDA originally approved the intramuscular (IM) formulation of the progestin in 2011.

Makena (hydroxyprogesterone caproate injection) is indicated to reduce the risk of preterm birth in women pregnant with one baby, and who have spontaneously delivered one preterm baby in the past.

“The prefilled Makena auto-injector offers a new administration option for patients and providers and contains a shorter, thinner non-visible needle compared to the intramuscular Makena injection,”​ AMAG spokesperson Sarah Connors told us.

Chief medical officer Julie Krop said the drug delivery system is designed to “address some of the known barriers to treatment of recurrent preterm birth, including lack of patient acceptance and adherence.”


The Makena finished drug product for commercial and clinical use is currently manufactured by Pfizer under a development and supply agreement, said Connors. 

“Antares is the exclusive supplier for the auto-injection system devices needed for the Markena auto-injector and Antares remains responsible for the manufacture and supply of the device and assembly of the Makena auto-injector,” ​said Connors.

“AMAG is responsible for providing Antares with the supply of the drug in pre-filled syringes to be used in the assembly of the finished auto-injector product,” ​she added.

AMAG expects the auto-injector product – which will be priced at parity with the IM formulation – to be available in March.

The company will continue to sell the IM formulation in single-dose and multi-dose vials.

Generic partner?

AMAG said Markena’s orphan drug exclusivity expired earlier this month, but does not anticipate a generic version of the IM formulation to enter the market until mid-year: “We have not announced details about the future authorised generic partner,” ​said Connors.

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