United Therapeutics to Feature Clinical Data Across its Commercial and Development Portfolio at the 2022 American Thoracic Society International Conference
United Therapeutics (UTHR) announced its participation in the 2022 American Thoracic Society (ATS) International Conference from May 13-18 in San Francisco. The company will present long-term extension data from the Tyvaso INCREASE study, and results from the ralinepag Phase 2 study and Orenitram FREEDOM-EV study. Additionally, eight posters will focus on real-world treprostinil use and other clinical studies. The conference aims to update the pulmonary hypertension community and will include a sponsored symposium on pulmonary hypertension associated with interstitial lung disease (PH-ILD).
- Presentation of long-term data from multiple studies (INCREASE, FREEDOM-EV, ralinepag) at a significant medical conference.
- Opportunity to engage with the pulmonary hypertension community.
- None.
Mini-symposia to focus on long-term extension data for the Tyvaso® INCREASE study, the ralinepag phase 2 study, and the Orenitram® FREEDOM-EV study
Poster presentations touch on real-world treprostinil use, Tyvaso DPI™, and other treprostinil clinical studies
“ATS 2022 will provide us with the opportunity to update the pulmonary hypertension community on long-term data with presentations on the INCREASE, FREEDOM-EV, and phase 2 ralinepag open label extension studies,” said
Mini-symposia include:
Mini-symposium,
Mini-symposium,
Mini-symposium,
Posters include:
Thematic poster session,
Thematic poster session,
Thematic poster session,
Thematic poster session,
Poster discussion session,
Poster discussion session,
Poster discussion session,
Rapid abstract poster discussion session,
Sponsored events include:
Sponsored Symposium,
The ATS 2022 Women’s Forum,
About TYVASO® (treprostinil) Inhalation Solution
Eyebrow (abbreviated) Indication
-
For the treatment of pulmonary arterial hypertension (PAH;
WHO Group 1) to improve exercise ability. -
For the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD;
WHO Group 3) to improve exercise ability.
INDICATION
TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of:
-
Pulmonary arterial hypertension (PAH;
WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with 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.
-
Pulmonary hypertension associated with interstitial lung disease (PH-ILD;
WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45% ) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25% ), andWHO Group 3 connective tissue disease (22% ).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.
- TYVASO inhibits platelet aggregation and increases the risk of bleeding.
- Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.
DRUG INTERACTIONS/SPECIFIC POPULATIONS
- The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
- Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to 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, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
- Safety and effectiveness in pediatric patients have not been established.
-
Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH‑ILD, 268 (
47.8% ) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.
ADVERSE REACTIONS
-
Pulmonary Arterial Hypertension (
WHO Group 1)
In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (
-
Pulmonary Hypertension Associated with ILD (
WHO Group 3)
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (
Please see Full Prescribing Information, the TD-100 and TD-300 TYVASO® Inhalation System Instructions for Use manuals, and other additional information at www.tyvaso.com or call 1‑877‑UNITHER (1-877-864-8437).
About Orenitram® (treprostinil) Extended-Release Tablets
Indication
Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension (PAH) (
Important Safety Information for Orenitram
Contraindications
-
Avoid use of Orenitram in patients with severe hepatic impairment (Child
Pugh Class C ) due to increases in systemic exposure.
Warnings and Precautions
- Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
- The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.
Adverse Reactions
-
In the 12-week, placebo-controlled, monotherapy study, and an event-driven, placebo-controlled, combination therapy study, adverse reactions that occurred at rates at least
5% higher on Orenitram than on placebo included headache, diarrhea, nausea, vomiting, flushing, pain in jaw, pain in extremity, hypokalemia, abdominal discomfort, and upper abdominal pain.
Drug Interactions
- Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.
Specific Populations
- Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies with Orenitram in pregnant women.
- It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.
- Safety and effectiveness of Orenitram in pediatric patients have not been established.
- Use of Orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. Caution should be used when selecting a dose for geriatric patients.
- There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients.
Please see Full Prescribing Information and Patient Information at www.orenitram.com or call 1-877-
About Remodulin® (treprostinil) Injection
Indication
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH;
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 using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) 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 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
-
In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes 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% ), rash (14% vs.11% ), 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 of ideal body weight, and monitor closely. 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 or if it affects the breastfed infant or milk production.
Please see accompanying Full Prescribing Information for Remodulin.
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-877-
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
You can learn more about what it means to be a PBC here: unither.com/PBC.
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 relating to upcoming medical conference posters and presentations, our ability to create value and sustain our success in the long-term, as well as our efforts to develop technologies that either delay the need for transplantable organs or expand the supply of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the
TYVASO, REMODULIN, and ORENITRAM are registered trademarks of
TYVASO DPI is a trademark of
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(202) 919-4097
ir@unither.com
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FAQ
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