The following is an excerpt from a statement from Genentech. Read the statement in its entirety here.
Genentech has announced an update on measures that are being taken in relation to the translucent particles that were identified in Hemlibra庐 (emicizumab-kxwh) in 2019 during a routine examination of product batches as part of quality assurance processes. Based on ongoing assessment to date, Genentech has not observed a safety risk to patients or an impact on the efficacy of Hemlibra.
Genentech聽recently proposed the use of a transfer needle with a filter for Hemlibra, to minimize particles. Filter devices are commonly used with biologics, such as antibody therapies, and other intravenously administered medicines, such as replacement factor VIII, to reduce the presence of these types of particles, which are commonly found in injected solutions. On August 19, 2020, the European Medicines Agency (EMA) approved the use of a transfer needle with a filter for Hemlibra.聽
Genentech has been communicating with the FDA to bring this transfer needle with a filter to the U.S. hemophilia community at the same time. The company has updated and submitted the Hemlibra label to the FDA with a formal approval expected later this year. In the meantime, since Genentech has already informed the FDA of this update, the filter needles are now available for the hemophilia community in the U.S. through their Specialty Pharmacies. Patients and caregivers can work with their healthcare providers and Speciality Pharmacy to receive the new needles. If their Speciality Pharmacy does not carry the filter needle at this time, patients should continue to use the transfer needles without a filter to prepare their Hemlibra dose until the transfer needles with a filter are available through their Specialty Pharmacy. As a reminder, Genentech does not believe that these particles pose a safety risk to patients or impact the efficacy of Hemlibra.聽
Read the statement in its entirety here.