FDA plans to revoke approval of Makena, the only preterm birth reduction therapy
Premature birth is the birth that occurs before 37th week of pregnancy. It effects approximately 1 in 10 infants. Multiple factors are responsible for preterm birth and premmies need more caution and intensive care ranges to surgery.
The mortality and morbidity associated with Preterm birth are significantly high. In an effort to regulate these complications, AMAG Pharmaceuticals worked over a period and developed Makena, hydroxyprogesterone caproate injection.
After the submission of clinical trial data, Makena was granted Accelerated approval by FDA in 2011. However due to non-concurrence of Phase III PROLONG trials and post market clinical benefits, the Center for Drug Evaluation and Research at FDA intends to withdraw the approval of it.
AMAG Pharmaceuticals may be left with an option to appeal and oral hearing. We need to look at the developments of this in near future.
