Reports of translucent particles of being detected in Hemlibra (emicizumab) in 2019 do not pose a safety risk or affect the therapy’s effectiveness and, according to Roche, health authorities have agreed that the treatment’s benefit/risk profile remains unchanged.
Yet, the company is proposing the use of a transfer needle equipped with a filter to reduce the amount of particles and give additional confidence to patients and physicians when using Hemlibra.
“This is one of many steps we are taking to continue to ensure the highest quality of our products; including changes to the manufacturing process with the objective to minimize the occurrence of particles in Hemlibra,” the company wrote in a statement.
Marketed by Genentech, a subsidiary of Roche, Hemlibra is an antibody-based therapy that has been approved to reduce or prevent spontaneous bleeds in adults and children with hemophilia A, with and without FVIII inhibitors (neutralizing antibodies).
The medication is normally administered by a subcutaneous (under-the-skin) injection, and requires a transfer needle to be taken from its vial, as well as a regular syringe to be administered.
The translucent particles, made of silicon oil and proteins, were first identified by the company during a routine examination of Hemlibra product batches in 2019. Although subsequent analyses demonstrated they are not toxic or dangerous to patients, and do not interfere with Hemlibra’s efficacy, Roche has adopted measures to reduce or eliminate such particles.
“Since our last statement issued on this matter in October 2019, we have been working closely with global and local health authorities regarding the various ways to reduce or eliminate these particles in Hemlibra,” Roche wrote.
As part of these efforts, Roche is now working to bring a transfer needle equipped with a filter to markets worldwide. The new transfer needle was already added to Hemlibra’s product label and approved by the European Medicines Agency last month.
Meanwhile, the company has submitted a similar request to the U.S. Food and Drug Administration, and is currently in discussions with other regulatory authorities.
“We are working closely with health authorities, the haemophilia community and our supply chain partners to ensure appropriate implementation, and anticipate market availability for the new administration kits with transfer needles with a filter in the EU [European Union] from the beginning of 2021,” Roche stated. “We will continue to work to ensure adequate measures are in place for global rollout of the transfer needle with a filter and will provide updates as needed.”
The company also stated that this new process for administering Hemlibra will not have any impact on the medication’s current prescribing methods. According to Roche, patients currently taking Hemlibra should continue receiving the therapy using a regular transfer needle without filter, until the new administration kit becomes available from their local distributor.
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