Amag risks Makena withdrawal

The greatest irony about the uproar over the preterm birth preventive drug Makena is that it apparently did not work to begin with. Amag Pharmaceuticals today reported that the Prolong trial, a confirmatory study to support Makena's accelerated approval in 2011, found no difference between Makena and placebo on incidence of preterm birth before 35 weeks or on neonatal mortality or morbidity. Makena was tested in women with a history of preterm birth. Amag executives were quick to blame the fact that much of the study had to be conducted in countries with different standards of perinatal care, since US obstetricians found their patients unwilling to enter a placebo-controlled trial. Nevertheless, the trial’s failure raises the question of whether regulators will seek to withdraw Makena, which was Amag’s biggest seller in 2018, but which has lost orphan drug exclusivity. Amag shares sank 20% in early trading today. Makena gained notoriety when its previous owner, K-V Pharmaceutical, raised the price of the drug to $1,500 per injection; its active ingredient, hydroxyprogesterone caproate, had previously been available from compounding pharmacies for around $10 per treatment. K-V later went bankrupt and changed its name to Lumara Health, which was then acquired by Amag. 

Makena mess? Data from Prolong
  Incidence of preterm birth Neonatal morbidity and mortality composite index
Makena 11.0% 5.4%
Placebo 11.5% 5.2%
P value 0.72 0.84
Source: Amag Pharmaceuticals.

Share This Article