SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C.,
Oct. 23, 2017 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced
approval by the U.S. Food and Drug Administration (FDA) of a new inhalation device, called the TD-300/A, for use with Tyvaso®
(treprostinil) Inhalation Solution (Tyvaso).
Tyvaso was originally approved by the FDA for the treatment of pulmonary arterial hypertension (PAH) in 2009, under a New Drug
Application covering a drug-device combination product consisting of Tyvaso drug product, as well as an ultrasonic nebulizer and
accessories referred to as the Tyvaso Inhalation System. Tyvaso is the most-prescribed inhalation therapy for PAH in the United States, and since its launch, United Therapeutics has been working on improvements to the Tyvaso
Inhalation System to aid patient compliance and enhance ease of use.
The TD-300/A is a significant step forward on that front. Designed based on patient and physician feedback, the new device has
a cleaner, more ergonomic design that includes single button operation, an intuitive user interface for adjusting breath counts,
a color, graphical display that leads patients through the inhalation process and displays time since last treatment, and an
internal, rechargeable battery.
"We are extremely proud of this new device, which is just one example of our commitment to improving the ease of
administration of treprostinil therapy so that more patients can benefit from our medicine," said Martine
Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We are not resting on our laurels with
this device, however. We recently launched a new program to develop a small, metered dose inhalation device for treprostinil, and
are planning to study the administration of inhaled treprostinil on a pro re nata 'as needed' basis, to provide more
flexibility for patients to use inhaled treprostinil where they need it, when they need it. And of course, we are continuing the
development of our advanced delivery devices for Remodulin®, such as our RemUnity™ subcutaneous pump, and RemoPro™, a prodrug
formulation of treprostinil."
"Tyvaso is an important element of our continuum of care, which provides a range of treprostinil therapy options across a
spectrum of PAH patients," said Michael Benkowitz, President and Chief Operating Officer. "The
launch of the TD-300/A, planned for mid-2018, will further optimize Tyvaso therapy for patients and, we believe, reduce the rate
of therapy discontinuation associated with the current nebulizer."
About Tyvaso
Tyvaso is a prostacyclin vasodilator indicated for the treatment of PAH (WHO Group 1) to improve exercise ability. Studies
establishing effectiveness included predominately patients with New York Heart Association (NYHA) Functional Class III symptoms
and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The effects
diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical
experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a
phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.
The efficacy of Tyvaso has not been established in patients with significant underlying lung disease (such as asthma or
chronic obstructive pulmonary disease). Patients with acute pulmonary infections should be carefully monitored to detect any
worsening of lung disease and loss of drug effect.
Tyvaso is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, Tyvaso may cause symptomatic
hypotension. Tyvaso dosage should be titrated slowly in patients with hepatic or renal insufficiency, as exposure to
treprostinil may be increased in these patients. Tyvaso inhibits platelet aggregation and increases the risk of
bleeding.
Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor, such as gemfibrozil, may increase exposure to treprostinil.
Co-administration of a CYP2C8 enzyme inducer, such as rifampin, may decrease exposure to treprostinil. Increased exposure is
likely to increase adverse events, whereas decreased exposure is likely to reduce clinical effectiveness.
Co-administration of the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to oral treprostinil. Co-administration of the
CYP2C8 enzyme inducer rifampin decreases exposure to oral treprostinil. It is unclear if the safety and efficacy of treprostinil
by the inhalation route are altered by inhibitors or inducers of CYP2C8.
Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse
developmental outcomes. However, there are risks to the mother and the fetus associated with pulmonary arterial
hypertension. It is not known whether treprostinil is excreted in human milk.
The most common adverse events seen with Tyvaso in ≥4% of PAH patients and more than 3% greater than placebo in the
placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/ pharyngolaryngeal pain (25%
vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%).
About United Therapeutics
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative
products to address the unmet medical needs of patients with chronic and life-threatening conditions. [uthr-g]
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 timing of the anticipated launch of the TD-300/A device, and its impact on the rate of therapy discontinuation for
Tyvaso, as well as further research and development efforts into new devices for Tyvaso and Remodulin, into a prodrug formulation
of treprostinil and into the administration of inhaled treprostinil on a pro re nata basis. 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
October 23, 2017, 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.
TYVASO and REMODULIN are registered trademarks of United Therapeutics Corporation. REMUNITY and REMOPRO are trademarks of
United Therapeutics Corporation.
View original content:http://www.prnewswire.com/news-releases/united-therapeutics-announces-fda-approval-of-third-generation-nebulizer-for-the-tyvaso-inhalation-system-300540953.html
SOURCE United Therapeutics Corporation