In the fall of last year Genentech reported that during a routine examination of batches of Hemlibra®, they found translucent particles composed of a therapeutic protein and an organic, non-toxic silicone oil (polydimethylsiloxane). While it is not unusual to find traces of these type particles in approved biologics, the greater than usual concentration in batches of Hemlibra® prompted the company to follow up. On October 7, 2019 NHF shared Genentech’s initial statement, plus the response provided by the Medical and Scientific Advisory Council (MASAC).
Hemlibra® is a subcutaneous injection currently indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors. To date, Genentech has not observed safety risks for hemophilia patients receiving Hemlibra® or impact on the product’s efficacy.
In a new community update, Genentech describes steps the company is taking in close coordination with U.S. Food and Drug Administration (FDA), including modifications to the manufacturing process and the addition of a transfer needle for added filtration.
“As an additional quality assurance measure to give further confidence to the community, we recently proposed the use of a transfer needle with a filter for Hemlibra®, to minimize particles,” reported Genentech. “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 19th the European Medicines Agency actually approved the use such a transfer needle/filter to be used with Hemlibra®. The company is now coordinating with the FDA to simultaneously bring the same transfer needle to the U.S.-based hemophilia patients. In fact, Genentech has already submitted a new label to the FDA that incorporates information on the needle/filter and is expecting formal approval later in 2020.
“In the meantime, since we’ve 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 specialty pharmacy to receive the new needles. If their specialty 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,” the company explains in a recent community update. “As a reminder, we do not believe that these particles pose a safety risk to patients or impact the efficacy of Hemlibra®.”
Source: Genentech, August 28, 2020