Roche and Genentech have announced an update on measures being taken in relation to the translucent silicon oil and protein particles that were identified in emicizumab (Hemlibra®) in 2019 during routine examination of product batches as part of quality assurance processes. To date, they have not seen a safety risk to patients nor an impact on efficacy and have been working closely with global and local health authorities on various ways to reduce or eliminate these particles in emicizumab.
In an August 31 update, Roche/Genentech stated that though these types of particles are common in biological manufacturing, they have proposed the use of a transfer needle with a filter to provide additional confidence to patients and physicians in emicizumab’s use and are collaborating with regulatory agencies and distributors to bring it to markets worldwide. The European Medicines Agency (EMA) approved this label update on August 19 and authorized use of the transfer needle with a filter for emicizumab, and a label update has also been submitted to the U.S.A. Food and Drug Administration (FDA) with a formal approval expected later this year, they reported. Roche/Genentech anticipate market availability for the new administration kits in the European Union from the beginning of 2021, and efforts are underway to bring them to the U.S.A. hemophilia community at the same time.
Filter devices are commonly used with biologics (such as antibody therapies) and other intravenously administered medicines (such as replacement factor) to reduce the presence of particles in an injected solution. “The use of a transfer needle with a filter for the administration of Hemlibra will not change the current prescribing method of the medicine,” Roche/Genentech stated. “Physicians should consult local prescribing details for the most up-to-date information. Patients should continue to use Hemlibra with the current transfer needle without filter until new administration kits become available through their local distributor.”
The transfer needle with filter is one of many steps being taken to continue to ensure emicizumab’s highest quality, including changes to the manufacturing process with the objective to minimize the occurrence of particles in emicizumab, they added.
Update on particles identified in Hemlibra® (emicizumab) (Roche, August 31, 2020)
Update on particles identified in Hemlibra® (emicizumab) (Genentech, August 28, 2020)
WFH Advisory on Particulate Matter in Emicizumab (Hemlibra) and Other Biologic Agents (October 8, 2019)