USFDA withdraws approval of drug Makena, Pharmaceutical company failed to submitte post market study, to evaluate saftey and to confirm the efficacy to FDA.

USFDA withdraws approval of drug Makena, the drug approved under accelerated approval pathway. The drug Makena is now no longer an approved drug, the drug was used for treatment as a preventive measure to reduce the risk of preterm birth in women having an earlier history of preterm birth.

The drug Makena was approved under the accelerated approval pathway which has a provision to withdraw or further evaluate and confirm the approval of the drug approved under this pathway.

The accelerated approval pathway requires the pharmaceutical company marketing the drug to conduct a post market study and confirm the efficacy, effectiveness and safety report and investigate untoward effects if any are associated with the drug. Which is also equivalent to a clinical trial, clinical study.

If the marketer of the drug does not conduct the post market study, then USFDA as a procedure withdraws approval for the drug. Therefore USFDA withdraws approval of drug Makena.

The accelerated approval pathway is used to approve drugs for the diseases for which there is no other drug or effective treatment is available, in this procedure the primary outcome of the drug study such as an ability to act in vitro on certain biochemical, biochemical assay or other change that a drug if given to the patient will provide the beneficial effect. The outcome of a clinical evaluation or study is called the clinical end point. In actual clinical study many patients are involved and study is done with the drug and an actual effect of the drug is evaluated, which is called the clinical end point.

The surrogate end point of a drug discovery or drug study involves assessment of the drugs ability to effect on the biochemical models which is considered to be imparting better effect on the patient’s body.

The drug Makena in discussion here is contains Hydroxyprogesterone caproate, which is a precursor of progesterone a hormone which regulates the gestational process drug Hydroxyprogesterone caproate act as agonist over progesterone receptors in human body and produces similar effect.

Why USFDA withdraws approval of drug Makena, and all generic drugs of Makena? 

Drug Makena was approved after consideration of surrogate end points. While the marketer of the drug has not provided post market study, therefore the US FDA has revoked the approval of the Makena, USFDA withdraws approval of drug Makena, and all generic drugs of Makena.

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