FDA Advisory Committee Sets Review Date for Mesoblast’s remestemcel-L in Pediatric Steroid-Refractory Acute Graft Versus Ho...
July 21 2020 - 5:33PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that the
Oncologic Drugs Advisory Committee (ODAC) of the United States Food
and Drug Administration (FDA) has scheduled a meeting
on August 13, 2020 to review data supporting the
Company’s Biologics License Application (BLA) for approval of
RYONCIL™ (remestemcel-L) for the treatment of steroid-refractory
acute graft versus host disease (SR-aGVHD) in children.
There are currently no FDA-approved treatments in
the United States for children under 12 with SR-aGVHD,
a potentially life-threatening complication of an allogeneic
bone marrow transplant for blood cancer. RYONCIL is under
Priority Review by the FDA with an action date of September 30,
2020, under the Prescription Drug User Fee Act (PDUFA).
The ODAC is an independent panel of experts that
provides advice and appropriate recommendations to the FDA based on
potential issues highlighted by the FDA during their review of the
efficacy and safety of marketed and investigational products for
use in the treatment of cancer.
The ODAC review will comprise two separate
sessions: a morning session which will discuss issues related
to the characterization and critical quality attributes of
remestemcel-L as they relate to clinical effectiveness, and
an afternoon session which will discuss results from clinical
trials included in the BLA.
Although the FDA will consider the recommendation
of the panel, the final decision regarding the approval of the
product is made by the FDA solely, and the recommendations by the
panel are non-binding.
About
RYONCIL™ (remestemcel-L)Mesoblast’s lead product
candidate, RYONCIL (remestemcel-L), is an investigational therapy
comprising culture-expanded mesenchymal stem cells derived from the
bone marrow of an unrelated donor. It is administered to patients
in a series of intravenous infusions. RYONCIL is believed to have
immunomodulatory properties to counteract the inflammatory
processes that are implicated in steroid-refractory acute graft
versus host disease by down-regulating the production of
pro-inflammatory cytokines, increasing production of
anti-inflammatory cytokines, and enabling recruitment of naturally
occurring anti-inflammatory cells to involved tissues.
About MesoblastMesoblast Limited (Nasdaq:MESO;
ASX:MSB) is a world leader in developing allogeneic (off-the-shelf)
cellular medicines. The Company has leveraged its proprietary
mesenchymal lineage cell therapy technology platform to establish a
broad portfolio of commercial products and late-stage product
candidates. Mesoblast has a strong and extensive global
intellectual property (IP) portfolio with protection extending
through to at least 2040 in all major markets. The Company’s
proprietary manufacturing processes yield industrial-scale,
cryopreserved, off-the-shelf, cellular medicines. These cell
therapies, with defined pharmaceutical release criteria, are
planned to be readily available to patients worldwide.
Mesoblast’s Biologics License Application to seek approval of
its product candidate RYONCIL™ (remestemcel-L) for pediatric
steroid-refractory acute graft versus host disease has been
accepted for priority review by the United States Food and Drug
Administration (FDA), and if approved, product launch in the United
States is expected in 2020. Remestemcel-L is also being developed
for other inflammatory diseases in children and adults including
moderate to severe acute respiratory distress syndrome. Mesoblast
is completing Phase 3 trials for its product candidates for
advanced heart failure and chronic low back pain. Two products have
been commercialized in Japan and Europe by Mesoblast’s licensees,
and the Company has established commercial partnerships in Europe
and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and
Singapore and is listed on the Australian Securities Exchange (MSB)
and on the Nasdaq (MESO). For more information, please see
www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter:
@Mesoblast
Forward-Looking StatementsThis announcement
includes forward-looking statements that relate to future events or
our future financial performance and involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. We make such forward-looking statements pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Forward-looking
statements should not be read as a guarantee of future performance
or results, and actual results may differ from the results
anticipated in these forward-looking statements, and the
differences may be material and adverse. Forward- looking
statements include, but are not limited to, statements about: the
timing, progress and results of Mesoblast’s preclinical and
clinical studies; Mesoblast’s ability to advance product candidates
into, enroll and successfully complete, clinical studies; the
timing or likelihood of regulatory filings and approvals; and the
pricing and reimbursement of Mesoblast’s product candidates, if
approved; Mesoblast’s ability to establish and maintain
intellectual property on its product candidates and Mesoblast’s
ability to successfully defend these in cases of alleged
infringement. You should read this press release together with our
risk factors, in our most recently filed reports with the SEC or on
our website. Uncertainties and risks that may cause Mesoblast’s
actual results, performance or achievements to be materially
different from those which may be expressed or implied by such
statements, and accordingly, you should not place undue reliance on
these forward-looking statements. We do not undertake any
obligations to publicly update or revise any forward-looking
statements, whether as a result of new information, future
developments or otherwise.
Release authorized by the Chief Executive.
For further information, please contact:
MediaJulie MeldrumT: +61 3 9639
6036E:julie.meldrum@mesoblast.com |
Kristen BothwellT: +1 917 613 5434E:kbothwell@rubenstein.com |
InvestorsSchond
GreenwayT: +212 880 2060E: schond.greenway@mesoblast.com |
Paul HughesT: +61 3 9639
6036E: paul.hughes@mesoblast.com |
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