Genentech Issues Statement on Hemlibra Particles; MASAC Responds

October 7, 2019

Today, Genentech provided the following statement regarding reports of particulate matter in vials of Hemlibra. You can read Genentech’s statement here and can read comments on the statement from NHF’s Medical and Scientific Advisory Council (MASAC) here.

The events of the past several months, including today’s announcement by Genentech, underscore the importance of the joint Safety Summit that NHF and HFA will hold in early 2020. As described in our joint letter of October 1, the Summit aims to bring patients and patient organizations together with medical providers, government, and industry to review current standards and processes in place to address product safety and discuss how these measures may be improved or expanded.

In the meantime, NHF and HFA will continue to dialogue with Genentech and with US regulators regarding today’s Genentech announcement. HFA and NHF will keep the bleeding disorders community informed as further information is gathered.

Please note that NHF and HFA do not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments, or opinions. Please consult your physician before use of any treatments.