SAN DIEGO, Jan. 15, 2021 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen
Biotech, Inc. (Janssen) has received U.S. Food and Drug
Administration (FDA) approval of DARZALEX FASPRO®
(daratumumab and hyaluronidase-fihj) in combination with
bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the
treatment of adult patients with newly diagnosed light chain (AL)
amyloidosis.1 DARZALEX FASPRO® is the
first and only FDA-approved treatment for patients with this rare
and serious blood disorder associated with the production of an
abnormal protein which leads to the deterioration of vital organs,
most notably the heart, kidneys and liver.1 This
indication is approved under accelerated approval and is based on
the combination's hematologic complete response rate (hemCR)
measure. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in a
confirmatory trial. DARZALEX FASPRO® is not
indicated and is not recommended for the treatment of patients with
light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV
cardiac disease or Mayo Stage IIIB outside of controlled clinical
trials.
"We are delighted that DARZALEX FASPRO®
utilizing our ENHANZE® technology has become the first
and only FDA-approved treatment for newly diagnosed patients with
AL amyloidosis," said Dr. Helen
Torley, president and chief executive officer. "AL
amyloidosis represents an area of high unmet medical need."
The FDA approval is based on positive results from the Phase 3
ANDROMEDA study, which were recently presented at the American
Society of Hematology (ASH) 2020 Annual Meeting. The study
evaluated DARZALEX FASPRO® in combination with
VCd, compared with VCd alone, a common treatment regimen offered to
adult patients with newly diagnosed AL amyloidosis.
5 Patients receiving treatment with DARZALEX
FASPRO® experienced a hemCR more than triple that of
patients receiving VCd alone (42 percent for D-VCd and 13 percent
for VCd; P<0.0001).1
Approximately 4,500 people in the U.S. develop this rare disease
each year.4 AL amyloidosis is a life-threatening
blood cell disorder that occurs when blood plasma cells in the bone
marrow produce amyloid deposits, which build up in vital organs and
eventually cause organ deterioration.3 The disease
can affect different organs in different people, but the most
frequently affected organs are the heart, kidneys, liver, spleen,
gastrointestinal tract and nervous system.2,3
About one-third of patients visit five or more doctors before
receiving a diagnosis, and 72 percent are diagnosed more than one
year after they first experience symptoms.3,4
Patients often have a poor prognosis due to the delay in diagnosis
of AL amyloidosis, which frequently presents with non-specific
symptoms that can mimic other, more common
conditions.6 As many as 30 percent of patients
with AL amyloidosis die within the first year after
diagnosis.7
About Halozyme
Halozyme is a biopharmaceutical company
bringing disruptive solutions to significantly improve patient
experiences and outcomes for emerging and established therapies.
Halozyme advises and supports its biopharmaceutical partners in key
aspects of new drug development with the goal of improving
patients' lives while helping its partners achieve global
commercial success. As the innovators of the ENHANZE®
technology, which can reduce hours-long treatments to a matter of
minutes, Halozyme's commercially-validated solution has positively
impacted more than 400,000 patient lives via five commercialized
products across more than 100 global markets. Halozyme and its
world-class partners are currently advancing multiple therapeutic
programs intended to deliver innovative therapies, with the
potential to improve the lives of patients around the globe.
Halozyme's proprietary enzyme rHuPH20 forms the basis of the
ENHANZE® technology and is used to facilitate the
delivery of injected drugs and fluids, potentially reducing the
treatment burden of other drugs to patients. Halozyme has licensed
its ENHANZE® technology to leading pharmaceutical and
biotechnology companies including Roche, Baxalta, Pfizer, Janssen,
AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon
Therapeutics. Halozyme derives revenues from these collaborations
in the form of milestones and royalties as the Company's partners
make progress developing and commercializing their products being
developed with ENHANZE®. Halozyme is headquartered in
San Diego. For more information
visit www.halozyme.com.
Safe Harbor Statement
In addition to historical
information, the statements set forth above include forward-looking
statements including, without limitation, statements concerning the
possible activity, benefits and attributes of ENHANZE®,
the possible method of action of ENHANZE®, its potential
application to aid in the dispersion and absorption of other
injected therapeutic drugs, and statements concerning certain other
potential benefits of ENHANZE® including facilitating
more rapid delivery of injectable medications through subcutaneous
delivery and potentially lowering the treatment burden for
patients. These forward-looking statements also include statements
regarding the product development efforts of Halozyme's
ENHANZE® partner. These forward-looking statements
involve risks and uncertainties that could cause actual results to
differ materially from those in the forward-looking statements. The
forward-looking statements are typically, but not always,
identified through use of the words "believe," "enable," "may,"
"will," "could," "intends," "estimate," "anticipate," "plan,"
"predict," "probable," "potential," "possible," "should,"
"continue," and other words of similar meaning. Actual results
could differ materially from the expectations contained in
forward-looking statements as a result of several factors,
including uncertainties concerning whether collaborative products
are ultimately developed or commercialized, unexpected expenditures
and costs, unexpected results or delays in development and
regulatory review including any potential delays caused by the
current COVID-19 global pandemic, unexpected regulatory approval
requirements, unexpected adverse events or patient outcomes from
being treated with the newly-approved ENHANZE®
co-formulated treatment referred to in this press release, and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in Halozyme's most
recent Annual and Quarterly Reports filed with the Securities and
Exchange Commission. Except as required by law, Halozyme undertakes
no duty to update forward-looking statements to reflect events
after the date of this release.
1 DARZALEX FASPRO® Prescribing
Information. Horsham, PA: Janssen
Biotech, Inc.
2 Mayo Clinic. Amyloidosis overview: symptoms and
causes.
https://www.mayoclinic.org/diseases-conditions/amyloidosis/symptoms-causes/syc-20353178.
Accessed January 2021.
3 Lousada I, Comenzo RL, Landau H, et al. Light
chain amyloidosis: patient experience survey from the Amyloidosis
Research Consortium. Advances in Therapy. 2015;32(10):920-928.
4 McCausland KL, et al. Patient.
2018;11(2):207-216.
5 Kastritis E, et al. Subcutaneous Daratumumab +
Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in
Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary
Results from the Phase 3 ANDROMEDA Study. Available at:
https://library.ehaweb.org/eha/2020/eha25th/303396/efstathios.kastritis.subcutaneous.daratumumab.2B.cycl%20ophosphamide.bortezomib.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Amedia%3D3%2Ace_i.
Accessed January 2021.
6 Mayo Clinic. Amyloidosis diagnosis and treatment.
https://mayocl.in/3jK50G4. Accessed January
2021.
7 Merlini G, et al. Light chain amyloidosis:
the heart of the problem. Haematologica.
2013;98(10):1492-1495.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.