RESEARCH TRIANGLE PARK, N.C.
and MANCHESTER, N.H., May 7, 2019 /PRNewswire/ -- United Therapeutics
Corporation (Nasdaq: UTHR) and DEKA Research & Development
Corp. today announced receipt of 510(k) clearance by the U.S. Food
and Drug Administration (FDA) for the Unity Subcutaneous Delivery
System for Remodulin (treprostinil) Injection, also referred to as
the RemUnity™ system.
The RemUnity system, which has been jointly developed by United
Therapeutics and DEKA, is indicated for subcutaneous delivery of
Remodulin to treat pulmonary arterial hypertension, or PAH. The
RemUnity system consists of a small, lightweight, durable pump that
is intended to have a service life of at least three years. The
RemUnity system uses disposable cartridges, which are connected to
the pump.
DEKA intends to submit a Special 510(k) filing to the FDA
shortly to enable cartridges to be pre-filled with Remodulin by
contracted specialty pharmacy distributors in order to improve
convenience for patients. United Therapeutics intends to launch the
product when this additional FDA clearance has been obtained.
United Therapeutics and DEKA are also developing a version of the
system that includes disposable cartridges that are pre-filled as
part of the manufacturing process.
"We developed the RemUnity system to address safety and patient
convenience problems with current subcutaneous infusion pumps,"
said Martine Rothblatt, Chairman and
Chief Executive Officer of United Therapeutics. "We believe the
RemUnity system reduces the risk of bolus dosing due to pump
failures and provides wider arrays of notifications, alerts and
alarms than current pumps. Most importantly, the acoustic volume
sensing technology and solid-state actuator of the RemUnity system
enables it to control Remodulin flow rates without the use of a
motor."
"We are excited to be launching this innovative delivery
technology with United Therapeutics. We are confident that it will
substantially improve the lives of patients who depend on UT's
unique pharmaceutical advances," said Dean
Kamen, Founder and President of DEKA. "We look forward to
continuing to deliver advanced solutions for patients in need."
About Remodulin (treprostinil) Injection
Indication
Remodulin is a prostacyclin vasodilator indicated for the
treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to
diminish symptoms associated with exercise. Studies establishing
effectiveness included patients with NYHA Functional Class II-IV
symptoms and etiologies of idiopathic or heritable PAH (58%), PAH
associated with congenital systemic-to-pulmonary shunts (23%), or
PAH associated with connective tissue diseases (19%).
In patients with PAH requiring transition from epoprostenol,
Remodulin is indicated to diminish the rate of clinical
deterioration. Consider the risks and benefits of each drug prior
to transition.
Important Safety Information for Remodulin
Warnings and Precautions
- Chronic intravenous (IV) infusions of Remodulin delivered with
an external infusion pump using an indwelling central venous
catheter are associated with the risk of blood stream infections
(BSI) and sepsis, which may be fatal. Therefore, continuous
subcutaneous (SC) infusion is the preferred mode of
administration.
- Avoid abrupt withdrawal or sudden large reductions in dosage of
Remodulin, which may result in worsening of PAH symptoms.
- Titrate slowly in patients with hepatic or renal insufficiency
because such patients will likely be exposed to greater systemic
concentrations relative to patients with normal hepatic or renal
function.
- Remodulin is a potent pulmonary and systemic vasodilator. In
patients with low systemic arterial pressure, treatment with
Remodulin may produce symptomatic hypotension
- Remodulin inhibits platelet aggregation and increases the risk
of bleeding.
Adverse Reactions
- Adverse Reactions: In clinical studies of SC Remodulin
infusion, the most common adverse events reported were infusion
site pain and infusion site reaction (redness and swelling). These
symptoms were often severe and sometimes required treatment with
narcotics or discontinuation of Remodulin. The IV infusion of
Remodulin with an external infusion pump has been associated with a
risk of blood stream infections, arm swelling, paresthesias,
hematoma, and pain. Other common adverse events (≥3% more than
placebo) seen with either SC or IV Remodulin were headache (27% vs.
23%), diarrhea (25% vs. 16%), nausea (22% vs. 18%), jaw pain (13%
vs. 5%), vasodilatation (11% vs. 5%), edema (9% vs. 3%), and
hypotension (4% vs. 2%).
Drug Interactions
- Remodulin dosage adjustment may be necessary if inhibitors or
inducers of CYP2C8 are added or withdrawn.
Specific Populations
- In patients with mild or moderate hepatic insufficiency,
decrease the initial dose of Remodulin to 0.625 ng/kg/min ideal
body weight. Remodulin has not been studied in patients with severe
hepatic insufficiency.
- Safety and effectiveness of Remodulin in pediatric patients
have not been established.
- It is unknown if geriatric patients respond differently than
younger patients. Caution should be used when selecting a dose for
geriatric patients.
- There are no adequate and well-controlled studies with
Remodulin in pregnant women. It is not known whether treprostinil
is excreted in human milk.
For additional information, visit http://www.remodulin.com or
call the Customer Service Line at 1-877-UNITHER
(1-877-864-8437).
About United Therapeutics
United Therapeutics Corporation focuses on the strength of a
balanced, value-creating biotechnology model. We are confident in
our future thanks to our fundamental attributes, namely our
obsession with quality and innovation, the power of our brands, our
entrepreneurial culture and our bioinformatics leadership. We also
believe that our determination to be responsible citizens – having
a positive impact on patients, the environment and society – will
sustain our success in the long term.
Through our wholly-owned subsidiary, Lung Biotechnology PBC, we
are focused on addressing the acute national shortage of
transplantable lungs and other organs with a variety of
technologies that either delay the need for such organs or expand
the supply. Lung Biotechnology is the first public benefit
corporation subsidiary of a public biotechnology or pharmaceutical
company. [uthr-g]
About DEKA
Based in Manchester, NH, DEKA
is a research and development company of more than 600 employees
comprised of engineering, manufacturing and quality assurance
professionals focused on the development of new technologies that
span a diverse set of applications. The company was founded in 1982
by Dean Kamen, an inventor who holds
hundreds of U.S. and foreign patents and numerous awards, many of
them for innovative medical devices that have expanded the
frontiers of healthcare worldwide.
Forward-looking Statements
Statements included in this press release that are not
historical in nature are "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include, among others, statements
regarding the commercialization of the RemUnity system and
additional regulatory submissions relating thereto, the ability of
our business model to create value, our ability to sustain
long-term success, and our organ transplantation research and
development programs. These forward-looking statements are subject
to certain risks and uncertainties, such as those described in our
periodic and other reports filed with the Securities and Exchange
Commission that could cause actual results to differ materially
from anticipated results. Such forward-looking statements are
qualified by the cautionary statements, cautionary language and
risk factors set forth in our periodic reports and documents filed
with the Securities and Exchange Commission, including our most
recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K. We claim the protection of the
safe harbor contained in the Private Securities Litigation Reform
Act of 1995 for forward-looking statements. We are providing this
information as of May 7, 2019, and
assume no obligation to update or revise the information contained
in this press release whether as a result of new information,
future events or any other reason.
REMODULIN is a registered trademark of United Therapeutics
Corporation.
REMUNITY is a trademark of United Therapeutics Corporation.
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SOURCE United Therapeutics Corporation; DEKA