Genentech’s hemophilia A treatment Hemlibra is among first products to include new dedicated section on patient experience data in its review documents as FDA begins implementing 21st Century Cures Act provision.
The US FDA’s recent approval of Genentech Inc.’s hemophilia A treatment Hemlibra (emicizumab-kxwh) shows how the agency is implementing a new transparency requirement related to patient experience data for drug and biologic applications.
Section 3001 of the 21st Century Cures Act, which was signed into law in December 2016, requires FDA to make public a brief statement regarding patient experience data reviewed as part of a drug and biologic application submitted after June 12. (Also see “21st Century Cures Revisions Tell FDA To Highlight ‘Patient Experience Data’” – Pink Sheet, 27 Nov, 2016.)
FDA said it has begun implementing Sec. 3001 by documenting what patient experience data have been submitted with an application through a new “Patient Experience Data” section in clinical review documentation.