Genentech Communication on Particulate Matter in Emicizumab (HEMLIBRA)
Genentech voluntarily announced the presence of translucent particles in emicizumab batches that exceed their current dossier standard of “practically particle free.” Regulatory authorities in the U.S., Switzerland, Canada, Japan, and Europe have reviewed the finding of this particulate matter. All of the agencies have determined that there is no change to the risk-benefit evaluation of emicizumab as it is currently manufactured and available for patient use as a result of these particulates. Genentech’s official statement:
During a routine examination of drug product batches, as part of our quality assurance systems and processes, hardly visible, translucent particles were identified in Hemlibra® (emicizumab), outside our particle specification.
These particles are inherent to the drug product and based on toxicology and safety assessments and review of available data, the benefit/risk profile of Hemlibra remains unchanged as a result. They consist of protein (Hemlibra drug substance) and silicone oil (PDMS, polydimethylsiloxane). Silicone oil is a non-toxic, organic polymer that is included in all parenteral medicines. Translucent particles are commonly observed and present in other approved biologics.
We have informed health authorities in March 2019. The European Medicines Agency (EMA), US Food and Drug Administration (FDA), Swissmedic, Health Canada, and the Ministry for Health, Labour and Welfare (MHLW) in Japan all agreed with our assessment that the benefit/risk profile of Hemlibra remains unchanged, and have supported the continued distribution of Hemlibra to patients to avoid therapy interruption. We have submitted the results of our final analysis to the health authorities and continue to engage with these health authorities.
We are committed to producing high quality products for our patients, which is why we have rigorous manufacturing monitoring, controls and testing in place for all our medicines, including Hemlibra.
Please contact your healthcare provider or Genentech Medical Communications (1-800-821-8590) for additional inquiries.
The Medical and Scientific Advisory Committee (MASAC) of the National Hemophilia Foundation issued the following statement: “Based on the information that MASAC has available at this time, including information on the assessments of regulatory health authorities, MASAC does not recommend a change in prescribing practice nor interruption in the use of emicizumab for patients already using the product. Any patient or caregiver who has questions or concerns about this matter should contact their Hemophilia Treatment Center. MASAC will continue to closely monitor this matter and provide additional updates as warranted.”
Additional information and the full MASAC statement can be accessed at: https://www.hemophilia.org/Newsroom/NHF-Community-News/Genentech-Issues-Statement-on-Hemlibra-Particles-MASAC-Responds