Techspec schreef op 25 augustus 2018 17:36:
www.accessdata.fda.gov/drugsatfda_doc...Het hieronder vermelde is op een formele wijze geeist door de FDA van Dyax Corporation t.a.v. Takhzyro (Lanadelumab) en dat is niet voor niets.........
POSTMARKETING COMMITMENTS SUBJECT TO THE REPORTING REQUIREMENTS UNDER SECTION 506B
We remind you of your postmarketing commitment:
3466-1 Submit the results of the ongoing Study DX-2930-04 with lanadelumab in patients 12 years of age and older with Type I or II hereditary angioedema (HAE) to provide long term efficacy and safety assessments, including clinical laboratory tests and immunogenicity, HAE attack data, and occurrence of adverse events including hypersensitivity, injection site reactions, LFT elevations, hospitalizations, and deaths.
The timetable you submitted on July 11, 2018, states that you will conduct this study according to the following schedule:
Final Report Submission: 05/2020
Bij een incident met fatale afloop is het mijns inziens einde oefening....
We gaan het zien....