CSL Behring announcement on their product Zemaira

Today, the Alpha-1 Foundation received the following communication from CSL Behring, regarding Zemaira®, their prescription drug for augmentation therapy for the treatment of Alpha-1 Antitrypsin Deficiency (Alpha-1). “The Alpha-1 Foundation is committed to provide timely- updated information received from CSL Behring to the Alpha-1 community. We encourage patients currently receiving Zemaira to contact their pharmacy and physician in respect to their individual prescription,” said Scott Santarella, Alpha-1 Foundation President & CEO.


ZEMAIRA® Alpha-1 Proteinase Inhibitor (Human) Update

CSL Behring remains committed to the patient community and fully dedicated to continuing to make ZEMAIRA available.

Following routine line maintenance, we have experienced manufacturing delays impacting supply plans which has resulted in a shortage of ZEMAIRA.

We are working tirelessly to resolve this matter but anticipate intermittent supply disruptions to continue. While supply disruptions may affect some ZEMAIRA patients over the coming months, we expect pharmacies and distributors to be able to order ZEMAIRA in the coming weeks. We are dedicated to resolving as quickly as possible and will provide an update as more information becomes available.

Patients are encouraged to contact their pharmacy regarding their individual prescription and also contact their physician about their treatment plan and alternative therapy options if necessary.

To stabilize future ZEMAIRA supply, CSL Behring has been evaluating long-term enhancements to our manufacturing capabilities including pursuing opportunities with contract manufacturing partners to help supplement our current filling facilities. As part of these efforts, CSL Behring entered a strategic partnership with Thermo Fisher which we anticipate will help alleviate supply constraints in the near future.

Patient focus is our fundamental and guiding company principle. We take our commitment to patients very seriously. We are keenly aware that our therapies are essential and are working hard to improve reliable ZEMAIRA supply.

Click here for FDA notice: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages