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SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Oct 31, 2022--
United Therapeutics Corporation (Nasdaq: UTHR ), a public benefit corporation, today announced that a preliminary analysis of the EXPEDITE study in patients suffering from World Health Organization ( WHO ) Group 1 pulmonary arterial hypertension ( PAH ) demonstrated that 79% of patients in the study achieved an Orenitram (treprostinil) extended-release tablet dose of at least 4 mg three times daily ( TID ), for a 12 mg total daily dose at 16 weeks, after an up to eight week induction treatment period with Remodulin (treprostinil) injection. Detailed study results will be made available through scientific disclosure at upcoming medical conferences and in peer-reviewed publications.
“The EXPEDITE trial represents a framework to get carefully selected PAH patients on clinically impactful oral doses of a critical class of medication safely and so much more timely,” said John Kingrey, M.D., director of the Pulmonary Hypertension center at INTEGRIS Baptist Medical Center. “I’m so pleased with how my patients did with this approach, as it really did expedite (pun intended!) their path to achieving increased prostacyclin dosages.”
“We’re delighted with the preliminary results from the EXPEDITE study, which provided patients a way to reach efficacious doses in a shorter period of time without having to commit to long-term pump therapy,” said Meredith Broderick, Pharm.D., J.D., Senior Director of Global Medical Affairs at United Therapeutics. “Along with our other phase 4 studies, EXPEDITE demonstrates our commitment to optimize available treatment options in order to help PAH patients better manage their disease.”
In EXPEDITE, patients enrolled in the study achieved a mean total daily Orenitram dose of 16.4 mg at 16 weeks with 79% of study subjects reaching the study’s primary endpoint of a 12 mg total daily dose. Secondary outcome measures included six-minute walk distance ( 6MWD ); the cardiac biomarker N-terminal pro-brain natriuretic peptide ( NT-proBNP ); WHO functional classification; echocardiography; risk scores; and health related quality of life, as assessed using the emPHasis-10 questionnaire.
A previous real world dosing analysis showed an average Orenitram dose of approximately 6 mg daily after 16 weeks without the induction protocol studied by the EXPEDITE study 1. In addition, scientific literature shows that higher doses of treprostinil have been associated with better outcomes for patients with PAH 2.
Treatment with Orenitram, three times daily, was well tolerated and the safety profile was consistent with previous Orenitram studies in PAH. In the study, several well-known treprostinil adverse events such as headache, nausea, and vomiting tended to improve after transition to Orenitram from Remodulin.
About the EXPEDITE study
EXPEDITE was a phase 4, multicenter, open-label 16-week study of Remodulin induction followed by oral Orenitram optimization in patients with PAH. Enrollment into the study was completed in May 2022 with a total of 36 patients enrolled. Twenty-nine patients completed the study. Once enrolled, patients were initiated on intravenous or subcutaneous Remodulin in an inpatient or outpatient setting and titrated to a minimum dose of 20 ng/kg/min over two to eight weeks. Patients were then transitioned to Orenitram over one to 21 days in the inpatient or outpatient setting. The primary endpoint was to evaluate the percentage of subjects achieving an Orenitram dose of 4 mg three times daily ( TID ) – or a total daily dose of 12 mg – or higher at week 16.
Secondary objectives of the study were to assess the effect of Orenitram treatment at 16 weeks after induction therapy with Remodulin on the following parameters:
Additional exploratory objectives of the study evaluated changes in biomarkers and pharmacogenomics from this study.
About Orenitram ® (treprostinil) Extended-Release Tablets
Indication
Orenitram is a prostacyclin mimetic indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%).
Important Safety Information for Orenitram
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Specific Populations
Please see Full Prescribing Information and Patient Information at www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).
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
Adverse Reactions
Drug Interactions
Specific Populations
Please see accompanying Full Prescribing Informationfor Remodulin.
For additional information, visit www.RemodulinPro.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. 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.
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 the results and anticipated impact of the EXPEDITE study, our commitment to optimize available treatment options in order to help PAH patients better manage their disease, our efforts to innovate for the unmet medical needs of our patients, to benefit our other stakeholders, and to pursue our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability 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 Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, 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 31, 2022 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.
1https://pubmed.ncbi.nlm.nih.gov/29582710/
2https://journals.sagepub.com/doi/full/10.1177/2045894020923956
REMODULIN and ORENITRAM are registered trademarks of United Therapeutics Corporation.
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CONTACT: Dewey Steadman at (202) 919-4097
Email:ir@unither.com
KEYWORD: NORTH CAROLINA MARYLAND UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS CARDIOLOGY
SOURCE: United Therapeutics Corporation
Copyright Business Wire 2022.
PUB: 10/31/2022 06:00 AM/DISC: 10/31/2022 06:01 AM
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