Jazz recognizes the critical need by patients for Erwinaze and is committed to providing timely, accurate information about Erwinaze supply to the patient and healthcare community.
Jazz has a long-standing commitment to addressing unmet needs for patients with serious health conditions. Jazz recognizes that any supply disruption for Erwinaze can impact patient care, and the company takes this supply disruption very seriously. Jazz has worked extensively with our partner, Porton Biopharma Limited (PBL), health authorities, customers and medical institutions to make Erwinaze available, and to educate healthcare providers on any accommodation necessary to address manufacturing deviations to maintain patient care.
There have been ongoing intermittent global shortages of Erwinaze due to ongoing quality and manufacturing issues at PBL, the sole manufacturer of Erwinaze that is wholly owned by the UK Department of Health and Social Care. PBL’s product quality and manufacturing issues have resulted in disruptions in our ability to make the product available to patients on a consistent basis, and requires Jazz to work on a batch-by-batch basis and also to provide modified product use instructions for the product.
Historically, Erwinaze was out of supply for a significant portion of the last two calendar years (for example, in the United States ~70% and ~44% of calendar days in 2019 and 2018, respectively). Jazz does not have reliable certainty of supply from PBL during the remainder of 2020. For the latest information on Erwinaze supply in the United States, visit www.ErwinazeSupply.com.
A result of ongoing shortages – in particular not having predictable, consistent supply – is that Erwinaze availability is not guaranteed for a full course of therapy. Since we are not able to guarantee ample supply, it is necessary that the ordering process limits ordering to a patient’s next scheduled course of Erwinaze treatment at a time. This process is intended to provide available supply to patients for whom there is an immediate treatment need and minimize surplus inventory held by institutions.
Jazz recognizes that any supply disruption for Erwinaze can impact patient care, and we take this supply disruption very seriously. In the past few years, all Erwinaze that PBL has been able to supply has been completely depleted due to demand for the product in markets where the product is licensed for distribution. As a consequence, there is generally no product inventory in stock that can be used to make up for any ongoing supply disruptions.
In order to provide transparency and to help inform treatment planning, the following is a summary of key issues related to the suitability and availability of Erwinaze.
Due to quality and manufacturing issues with product manufactured by PBL over the past few years, product made available to Jazz by PBL is not ready for release to patients. Jazz needs to perform the following activities to ensure the suitability of the product for patients:
In addition, many batches have additional and specific quality and/or manufacturing issues that require additional activities and time to ensure product is suitable for release to patients. These activities include third-party analytical testing, expert consultant review, clinical risk assessments and engagement with regulatory authorities.
Although every effort is made to expedite this process, these activities take additional time before product is available for patients.
Due to the product quality and manufacturing issues at PBL, all Erwinaze batches since January 2016 have required special handling instructions to address potential particulate matter.
In addition, in the United States a Dear Healthcare Provider letter that contains Special Handling Instructions for administration in an effort to minimize potential adverse events related to potential particulate matter accompanies each batch of Erwinaze.
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