Cerus Corporation Announces FDA Approval of Extended Shelf Life for INTERCEPT Platelet Processing Sets – Doubling Previous Shelf Life
26 Marzo 2024 - 6:30AM
Business Wire
Cerus Corporation (Nasdaq: CERS) today announced that the U.S.
Food and Drug Administration (FDA) has granted approval of 12-month
shelf life for INTERCEPT Platelet Processing Sets, from the date of
manufacture, effective immediately. This approval extends the set
shelf life by six months from the existing six-month shelf life
that took effect following a set component change last year. All
INTERCEPT Platelet Processing Sets in both customer and Cerus
inventories are now eligible for this six-month extension. This
shelf-life extension applies to all sizes of INTERCEPT Platelet
Processing Sets currently available in the U.S.
“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 Concord, California, the company
develops and supplies vital technologies and pathogen-protected
blood components to blood centers, hospitals, and ultimately
patients who rely on safe blood. The INTERCEPT Blood System for
platelets and plasma is available globally and remains the only
pathogen reduction system with both CE mark and FDA approval for
these two blood components. The INTERCEPT red blood cell system is
under regulatory review in Europe, and in late-stage clinical
development in the US. Also in the US, the INTERCEPT Blood System
for Cryoprecipitation is approved for the production of Pathogen
Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to
as INTERCEPT Fibrinogen Complex), a therapeutic product for the
treatment and control of bleeding, including massive hemorrhage,
associated with fibrinogen deficiency. For more information about
Cerus, visit www.cerus.com and follow us on LinkedIn.
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 Ukraine and Israel, rising interest
rates, inflation and the evolving effects of the COVID-19 pandemic,
(b) Cerus’ manufacturers could be unable to comply with extensive
FDA and foreign regulatory agency requirements, and (c) Cerus may
be unable to maintain its supply agreements with its third party
suppliers; risks associated with Cerus’ need for additional
funding; risks associated with macroeconomic developments,
including ongoing military conflicts in Ukraine and Israel and the
COVID-19 pandemic and resulting global economic and financial
disruptions, and the current and potential future negative impacts
to Cerus’ business operations; and other risks detailed in Cerus’
filings with the Securities and Exchange Commission, including
under the heading “Risk Factors” in Cerus’ Annual Report on Form
10-K for the year ended December 31, 2023, filed with the SEC March
5, 2024. Cerus disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press
release.
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version on businesswire.com: https://www.businesswire.com/news/home/20240326078043/en/
Jessica Hanover – Vice President, Corporate Affairs Cerus
Corporation 925-288-6137
Cerus (NASDAQ:CERS)
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