SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Jan. 13, 2021 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ:UTHR) today announced that results from the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) have been published online in the New England Journal of Medicine. Results from INCREASE, the largest and most comprehensive completed study of adult patients with PH-ILD, showed that treatment with inhaled Tyvaso was well tolerated and improved the exercise capacity measure of six-minute walk distance (6MWD) by 31 meters relative to placebo at Week 16 (p<0.001) using the mixed model repeated measurement analysis. Additionally, patients treated with Tyvaso experienced significant improvements in other clinically meaningful outcomes, including a decreased risk of clinical worsening, an improvement in forced vital capacity, and a reduction in exacerbation of underlying lung disease.
Interstitial lung disease (ILD) is a group of lung diseases in which marked scarring occurs within the lungs. It is often complicated by pulmonary hypertension (PH; high blood pressure in the lungs). PH is estimated to affect at least 15% of patients with ILD (approximately 30,000 PH-ILD patients) and may affect up to 86% of patients with more severe ILD. Currently, no therapy is approved by the U.S. Food and Drug Administration (FDA) to treat this serious, life-threatening disease.
“Patients with both interstitial lung disease and pulmonary hypertension are more likely to have a worse course of disease and worse survival rate than patients with interstitial lung disease alone. They often have a very poor quality of life and are significantly limited because of severe shortness of breath despite supplemental oxygen,“ said Steven D. Nathan, M.D., an INCREASE study investigator and Steering Committee member, Director of the Advanced Lung Disease Program and Director of the Lung Transplant Program at Inova Fairfax Hospital in Falls Church, Va., and Professor of Medicine at Virginia Commonwealth University-Inova Campus. “With no therapies currently approved for PH-ILD, the positive efficacy and notable safety outcomes demonstrated in the INCREASE study are very encouraging. Having an approved inhaled treatment to offer my patients with PH-ILD would be transformational for the medical community and, importantly, for patients living with this disease.“
United Therapeutics submitted a supplemental New Drug Application (sNDA) for Tyvaso for the treatment of PH-ILD based on the results of the INCREASE study. The sNDA was accepted by the FDA for review, and the company expects the agency's review to be complete in April 2021.
“We are thrilled that the positive pivotal INCREASE study results were published in such a prestigious journal,“ said Leigh Peterson, Ph.D., Vice President, Product Development at United Therapeutics. “Based on the final data set from INCREASE, we are confident that Tyvaso will provide clinical benefit to patients with PH-ILD, who are in need of a safe and effective therapy. If approved, Tyvaso will be the first and only therapy approved for the treatment of this serious disease, heralding a significant advance in the way these patients are managed.“
INCREASE Study Design and ResultsThe multicenter, randomized, double-blind, placebo-controlled, 16-week, parallel-group INCREASE study evaluated Tyvaso in adult patients suffering from World Health Organization (WHO) Group 3 PH-ILD. A total of 326 patients were enrolled at 93 centers and randomized to inhaled Tyvaso (n=163) four times daily or placebo (n=163). United Therapeutics previously announced topline data from INCREASE showing it met all primary and secondary endpoints.
The primary efficacy endpoint was the change in six-minute walk distance (6MWD) measured at peak exposure from baseline to Week 16. Results showed that Tyvaso significantly increased 6MWD by 31 meters as analyzed using the Mixed Model Repeated Measurement (p<0.001). When analyzed using a pre-specified worst case imputation for missing data and Hodges-Lehmann estimate, Tyvaso improved 6MWD by 21 meters relative to placebo over the same time period (p=0.0043). The benefits of Tyvaso were observed across subgroups, including etiology and severity of PH-ILD, ...
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