The US Food and Drug Administration (FDA) on Thursday finalized guidance providing recommendations for developing drugs to treat pediatric patients with partial onset seizures (POS) by extrapolating efficacy data from drugs approved to treat adult patients with the condition.
The three-page guidance finalizes a draft version released for comment in February 2018. Most notably, the final guidance extends the age range of patients for whom efficacy data can be extrapolated to from four years and older to two years and older.
FDA notes that the guidance does not apply to the development of drugs to treat other types of seizures, nor does it apply to clinical development programs for treating POS in children less than two years of age.
“Efficacy can be extrapolated from adults to pediatric patients when it is reasonable to assume that children, compared with adults, have a similar progression of disease, similar response of disease to treatment, and similar exposure-response relationship. After excluding children with POS associated with epileptic encephalopathies, such as Lennox-Gastaut syndrome, the pathophysiology of POS appears similar in adults and pediatric patients 2 years of age and older,” FDA writes…