United Therapeutics to Present New Data at CHEST Annual Meet
Oct 11, 2021 7:03:10 GMT -5
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United Therapeutics to Present New Data at CHEST Annual Meeting 2021
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 11, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, today announced new data on pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented as posters at CHEST 2021, the annual meeting of the American College of Chest Physicians, which will be held virtually October 17-20. United Therapeutics and its collaborators are presenting a total of 10 abstracts across a broad range of studies in PAH and PH-ILD, including pharmacokinetic (PK) data from the BREEZE study of Tyvaso DPI™.
"Our decades-long commitment to pulmonary hypertension has yielded favorable results, and the data we're presenting at CHEST 2021 show the potential for our research to help transform patients' lives," said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "We will continue our work to evolve the standards of care in pulmonary hypertension to help improve the quality of life for patients living with this condition."
The CHEST meeting will feature a poster detailing PK data from the BREEZE study of Tyvaso DPI in patients with PAH. The BREEZE study enrolled 51 subjects on a stable regimen of Tyvaso who were transitioned to Tyvaso DPI at a corresponding treprostinil dose. The primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inhalation Solution. Secondary objectives of the study included changes in six-minute walk distance, device preference and satisfaction as evaluated through the Preference Questionnaire for Inhaled Treprostinil Devices, and patient-reported PAH symptoms and impact. Top line data showing the BREEZE study met its primary objective were released in January 2021, and detailed data on the primary and secondary objectives were presented in September 2021. PK data from a healthy volunteer study of Tyvaso DPI will be presented at a future scientific forum.
Other Tyvaso posters will detail subgroup data on dose response and hemodynamics collected during the INCREASE study of Tyvaso Inhalation Solution in patients with PH-ILD. Top line results from the INCREASE study were issued in February 2020 and additional data were issued in June 2020 and January 2021.
Key Orenitram® posters include real world interim data from the ADAPT registry of Orenitram patients and an analysis of U.S. medical claims for Orenitram and selexipag patients one year into treatment.
United Therapeutics abstracts in the CHEST 2021 virtual program include:
Tyvaso abstracts
About TYVASO® (treprostinil) Inhalation Solution
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%), and WHO 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 (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled 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%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.
Pulmonary Hypertension Associated with ILD (WHO Group 3)
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions were similar to the experience in studies of PAH.
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).
United Therapeutics to Present New Data at CHEST Annual Meeting 2021
- A total of 10 abstracts reinforce United Therapeutics' commitment to advancing research in pulmonary hypertension
- Additional subgroup analyses evaluate data from the Tyvaso® INCREASE study in PH-ILD
- Additional new data evaluate the pharmacokinetics of Tyvaso DPI™ from the BREEZE study
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 11, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, today announced new data on pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented as posters at CHEST 2021, the annual meeting of the American College of Chest Physicians, which will be held virtually October 17-20. United Therapeutics and its collaborators are presenting a total of 10 abstracts across a broad range of studies in PAH and PH-ILD, including pharmacokinetic (PK) data from the BREEZE study of Tyvaso DPI™.
"Our decades-long commitment to pulmonary hypertension has yielded favorable results, and the data we're presenting at CHEST 2021 show the potential for our research to help transform patients' lives," said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "We will continue our work to evolve the standards of care in pulmonary hypertension to help improve the quality of life for patients living with this condition."
The CHEST meeting will feature a poster detailing PK data from the BREEZE study of Tyvaso DPI in patients with PAH. The BREEZE study enrolled 51 subjects on a stable regimen of Tyvaso who were transitioned to Tyvaso DPI at a corresponding treprostinil dose. The primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inhalation Solution. Secondary objectives of the study included changes in six-minute walk distance, device preference and satisfaction as evaluated through the Preference Questionnaire for Inhaled Treprostinil Devices, and patient-reported PAH symptoms and impact. Top line data showing the BREEZE study met its primary objective were released in January 2021, and detailed data on the primary and secondary objectives were presented in September 2021. PK data from a healthy volunteer study of Tyvaso DPI will be presented at a future scientific forum.
Other Tyvaso posters will detail subgroup data on dose response and hemodynamics collected during the INCREASE study of Tyvaso Inhalation Solution in patients with PH-ILD. Top line results from the INCREASE study were issued in February 2020 and additional data were issued in June 2020 and January 2021.
Key Orenitram® posters include real world interim data from the ADAPT registry of Orenitram patients and an analysis of U.S. medical claims for Orenitram and selexipag patients one year into treatment.
United Therapeutics abstracts in the CHEST 2021 virtual program include:
Tyvaso abstracts
- BREEZE: Clinical Outcomes and Pharmacokinetics (PK) of Treprostinil Inhalation Powder (Tyvaso DPI)
- Dose-response Analysis of Inhaled Treprostinil in Pulmonary Hypertension Associated with Interstitial Lung Disease and Its Effects on Clinical Worsening
- The Impact of Hemodynamic Parameters on Inhaled Treprostinil Treatment Response – A Subgroup Analysis from the INCREASE Trial
- Healthcare Resource Utilization and Treatment Patterns Before and After Initiation of Inhaled Treprostinil
- Burden of Illness in Patients with Pulmonary Hypertension due to Interstitial Lung Disease: A Real-World Analysis Using US Claims Data
- Comparison of Effects of Inhaled Treprostinil on Lung Function in Patients with Pulmonary Hypertension Associated with Interstitial Lung Disease and Pulmonary Arterial Hypertension
- Screening for Pulmonary Hypertension in Patients with Interstitial Lung Disease: Recommendations from a Delphi Consensus Panel
About TYVASO® (treprostinil) Inhalation Solution
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%), and WHO 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 (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled 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%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.
Pulmonary Hypertension Associated with ILD (WHO Group 3)
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions were similar to the experience in studies of PAH.
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).