FDA approves new injection product to reduce preterm birth risk


Makena, a progestin injection for the prevention of preterm birth that has been approved for use since 2011, has received U.S. Food and Drug Administration approval for a subcutaneous auto-injection product to supplant its intramuscular injection formulation, announced its manufacturer, AMAG Pharmaceuticals, on Feb. 14.

The intramuscular injection’s 7-year orphan drug exclusivity expired earlier in February. AMAG plans to offer both products priced at parity, according to the company’s press release. The newer product has a smaller, thinner needle. Both products are intended for use in a woman who has a singleton pregnancy of less than 37 weeks’ gestation and who has had a prior spontaneous preterm singleton delivery. The intramuscular injection is available in both single-dose and multidose vials.

Makena revenues in 2017 were nearly $400 million. The drug was the subject of a price controversy in 2011 under its maker at the time, KV Pharmaceutical, which subsequently cut the price by more than half.

The injection has several contraindications, including blood clots and hormone-sensitive cancers. Its efficacy is based on an improved number of women who used it and were delivered at more than 37 weeks’ gestation rather than on a directly demonstrated clinical benefit in neonatal morbidity or mortality.

Read more in AMAG’s press release.

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