Because there are a number of patients in immediate need of Erwinaze treatment, we kindly request that healthcare professionals and hospitals only order Erwinaze for patients who are currently undergoing treatment or beginning treatment. We thank you for your understanding and support.
Thank you for your continued understanding and patience during this time. Please check this website periodically for information regarding Erwinaze supply. You can also use this site as a resource to learn more about preparation and handling or administration.
Parents and caregivers
Jazz appreciates that parents and caregivers may have questions or concerns about how this situation may affect a patient’s care. Jazz recommends you speak to the treating healthcare provider, who is the most qualified person to answer questions about patient treatment plans. You may also find answers to your questions or concerns on our Patient FAQs page.
Erwinaze® (asparaginase Erwinia chrysanthemi) supply in the United States
Jazz recognizes the critical need for Erwinaze and is committed to providing timely information about Erwinaze supply to the patient and healthcare community.
Jazz has dedicated this website solely to sharing current supply updates so that healthcare providers have the information they need to make the best clinical decisions for their patients. While this site will not be able to address every question, Jazz’s goal is to provide as much clarification and context as possible about supply. This page is not intended to address clinical matters or general product questions.
Historical worldwide shortage
There have been ongoing intermittent global shortages of Erwinaze due to quality and manufacturing issues, which have caused disruptions in our ability to make the product available to patients on a consistent basis. These issues also require Jazz to work on a batch-by-batch basis and to provide modified product use instructions for the product.
Additional Efforts to Ensure Suitability for Patient Use
Jazz takes several steps to review manufacturing and quality information provided to us to ensure patient safety. Any issues identified with the product during this review must be investigated and resolved prior to Jazz picking up product for packaging and labeling. This process can take several months and requires information and assistance from the manufacturer.
If product is confirmed suitable for release to patients, it then undergoes packaging, labelling and distribution and, in some instances, review by Regulatory Authorities prior to release.
At Jazz, patients are our top priority and we are committed to doing what we can to make quality product available to patients.
Jazz recognizes that any supply disruption for Erwinaze can impact patient care, and we take this supply disruption very seriously. Jazz has worked extensively with the manufacturer, health authorities, customers and medical institutions to make Erwinaze available, and to educate healthcare providers on product quality issues that may patient care.
Jazz strives to provide transparent and timely updates regarding Erwinaze inventory to patients, parents, caregivers, healthcare providers, and others whom the Erwinaze shortage may impact. Jazz wants to ensure we maintain this community’s trust in Erwinaze and Jazz Pharmaceuticals.
The Future of Erwinaze Distribution
In 2020, Porton Biopharma Limited (PBL), the owner of Erwinaze, announced its decision to move forward with a new partner, Clinigen, to commercialize and distribute Erwinaze in 2021. Jazz’s agreement with PBL ends on December 31, 2020, but Jazz has the right to distribute certain Erwinaze inventory in 2021, subject to quality and regulatory reviews of the product made available to Jazz for distribution. Jazz cannot speculate about what PBL and its new partner’s distribution plans are for Erwinaze following the end of our partnership with PBL.
Jazz remains committed to this patient population and we continue to recognize that any Erwinaze supply disruption has the potential to impact patient care. We take any supply disruption very seriously and will continue to take steps to support patient care during the time period that we are responsible for Erwinaze distribution.