Cerus Corporation Announces FDA Approval of Extended Shelf Life for INTERCEPT Platelet Processing Sets – Doubling Previous Shelf Life
“We are pleased with this successful and timely outcome to our regulatory filing with the FDA to re-establish a longer shelf life for INTERCEPT Platelet Processing Sets in the U.S.,” said Vivek Jayaraman, Cerus’ chief operating officer. “We expect that this extension will provide relief to our customers’ and our supply chains and will give customers the flexibility to balance inventory levels with current and future demand while reducing product expiration risk.”
The Company is continuing to generate additional data to pursue potential shelf life extension from the FDA beyond 12 months for the INTERCEPT Platelet Processing Sets.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to: the impact of the six-month extension in shelf-life of the INTERCEPT Platelet Processing sets granted by FDA on our customers and supply chains; the potential for shelf life extension beyond 12 months by FDA for the INTERCEPT Platelet Processing sets; and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the uncertain and time-consuming development and regulatory process, including: (a) the risk that Cerus may unable to generate and submit stability data to FDA to support the extension of the shelf life for the INTERCEPT Platelet Processing sets beyond 12 months in a timely manner or at all and (b) the risk that any changes to the INTERCEPT Platelet Processing sets may require additional aging and stability data in order to satisfy regulators and maintain historical label claims; risks related to product safety; Cerus’ ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus’ supply chain could be negatively impacted as a result of the evolving impact of macroeconomic developments, including the ongoing military conflicts in
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Jessica Hanover – Vice President, Corporate Affairs
Cerus Corporation
925-288-6137
Source: Cerus Corporation