Pulmonary circulation

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Friday, March 22, 2024
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RARITAN, N.J., March 22, 2024  /PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.1 OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.1

Key Points: 
  • Historically, this required patients to take multiple pills because no single-tablet combination therapy targeting two or more pathways was available," said Kelly Chin, M.D., Professor of Internal Medicine and Director of the Pulmonary Hypertension Program at UT Southwestern Medical Center, and an investigator in the A DUE study.
  • The FDA's approval of OPSYNVI® is based on the results from the pivotal Phase 3 A DUE study , in which OPSYNVI® demonstrated greater reduction in Pulmonary Vascular Resistance (PVR) after 16 weeks versus tadalafil or macitentan monotherapy.
  • "People with PAH often live with the burden of taking many pills each day, which can pose challenges," said James F. List, M.D., Ph.D., Global Therapeutic Area Head, whose team oversees a portfolio of programs including Pulmonary Hypertension at Johnson & Johnson.
  • "We're thrilled to bring this single-tablet combination therapy to patients, as it has the potential to optimize disease management and fulfill a significant unmet need in supporting recently updated treatment guidelines that call for initial or early combination treatment."

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Tuesday, May 30, 2023
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RARITAN, N.J., May 30, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.1 The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in this PAH patient population.

Key Points: 
  • "Today's submission builds on our decades-long commitment to address patient needs and bring forward medicines with the potential to offer an improved standard of PAH care."
  • Currently, this requires patients to take multiple pills as no single tablet that combines two or more PAH-specific pathways is available for these patients.3
    The NDA is based on late-breaking data from the Phase 3 A DUE study, which met its co-primary endpoints, demonstrating marked pulmonary hemodynamic improvement.
  • The safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafilii,iii.
  • The open label arm of the A DUE study is ongoing.

Aerovate Therapeutics Publishes Results of Phase 1 Study Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension in ERJ Open Research

Retrieved on: 
Thursday, November 17, 2022
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AV-101 is being developed to address abnormal cellular proliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the pathophysiology of pulmonary arterial hypertension (PAH).

Key Points: 
  • AV-101 is being developed to address abnormal cellular proliferation and resistance to apoptosis in the pulmonary vasculature, which are key features of the pathophysiology of pulmonary arterial hypertension (PAH).
  • This allows for the potential to maximize efficacy while limiting the adverse events observed with oral imatinib.
  • Aerovates Phase 2b/Phase 3 trial, called IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial), is underway to evaluate the safety and efficacy of inhaled AV-101 in adults with PAH.
  • IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with PAH that will continuously enroll patients as the study progresses from Phase 2b to Phase 3.

Aerovate Therapeutics Presents Novel Phase 2b/Phase 3 IMPAHCT Trial Design at CHEST Annual Meeting 2022

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Tuesday, October 18, 2022
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WALTHAM, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today presents the design of IMPAHCT (Inhaled iMatinib for Pulmonary Arterial Hypertension Clinical Trial; AV-101-002), a Phase 2b/Phase 3 trial investigating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension (PAH), at the American College of Chest Physicians Annual Meeting (CHEST 2022) in Nashville, TN.

Key Points: 
  • WALTHAM, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today presents the design of IMPAHCT (Inhaled iMatinib for Pulmonary Arterial Hypertension Clinical Trial; AV-101-002), a Phase 2b/Phase 3 trial investigating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension (PAH), at the American College of Chest Physicians Annual Meeting (CHEST 2022) in Nashville, TN.
  • Part two (Phase 3): Part two begins immediately following enrollment of the last participant in the Phase 2b part of the trial and signifies the start of enrollment in the Phase 3 trial.
  • Part two uses the same dosing as in the Phase 2b part of the trial with participants randomized across three AV-101 doses and placebo.
  • Part three (Phase 3): This part of the trial will start once an optimal dose of AV-101 has been selected based on the Phase 2b results.

Merck Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Monday, October 10, 2022
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The overall safety profile of sotatercept in STELLAR was in general consistent with what has been observed in Phase 2.

Key Points: 
  • The overall safety profile of sotatercept in STELLAR was in general consistent with what has been observed in Phase 2.
  • We believe that in totality, the results observed in the STELLAR study suggest that sotatercept has the potential to transform the treatment of patients with PAH.
  • Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation.
  • Sotatercept was designed to rebalance pro-proliferative (ActRIIA/Smad2/3-mediated) and anti- proliferative (BMPRII/Smad1/5/8-mediated) signaling associated with pulmonary arterial wall and right ventricular remodeling.

Aerovate Therapeutics Presents Phase 1 Data for AV-101, A Novel Dry Powder Inhaled Formulation of Imatinib Being Developed for the Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Monday, May 16, 2022
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WALTHAM, Mass., May 16, 2022 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today presents Phase 1 results at the American Thoracic Society (ATS) International Conference in San Francisco. Aerovate’s data show that AV-101, a novel inhaled dry powder formulation of imatinib, was generally well-tolerated by healthy adult volunteers with no serious adverse events reported.

Key Points: 
  • Aerovates data show that AV-101, a novel inhaled dry powder formulation of imatinib, was generally well-tolerated by healthy adult volunteers with no serious adverse events reported.
  • Aerovate designed AV-101, a dry powder inhaled formulation of imatinib, to target imatinibs anti-proliferative activity in the pulmonary vasculature by direct delivery to the lungs while potentially avoiding the treatment-limiting systemic toxicities seen with oral imatinib.
  • Aerovates Phase 1 trial evaluated single and multiple ascending doses of AV-101 administered by inhalation for safety, tolerability, and pharmacokinetics in healthy adult volunteers.
  • Aerovate's initial focus is on advancing AV-101, its proprietary dry powder inhaled formulation of the drug imatinib for the treatment of patients with PAH.

BodiMetrics' Prevention circul+ Ring Sleep Apnea Detection Comparable to Sleep Lab Tests

Retrieved on: 
Tuesday, March 15, 2022
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ROME, March 15, 2022 /PRNewswire/ -- BodiMetrics announced today the results of a 164 patient clinical study that compared their Prevention circul+ wearable ring device versus traditional polysomnography (PSG) test. The results revealed that the circul+ compares favorably to the conventional and bulkier PSG systems widely used for sleep apnea detection.

Key Points: 
  • The results revealed that the circul+ compares favorably to the conventional and bulkier PSG systems widely used for sleep apnea detection.
  • Miguel Gonalves Meira e Cruz presented the study results to a room of top sleep doctors at the 2022 World Sleep Congress in Rome, Italy, considered the premier global event for sleep science.
  • "The Prevention circul+ has shown itself to be among the best consumer health devices today," said Meir Kryger, MD, FRCPC, professor of pulmonary and sleep medicine at Yale.
  • "These latest results validate that the Prevention circul+ Ring can provide medical-grade data for consumers.

Aerovate Therapeutics Announces Initiation of IMPAHCT Phase 2b/Phase 3 Trial of AV-101 In Pulmonary Arterial Hypertension

Retrieved on: 
Wednesday, December 15, 2021
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We are excited and humbled to initiate this Phase 2b/Phase 3 trial of AV-101, said Tim Noyes, Chief Executive Officer at Aerovate.

Key Points: 
  • We are excited and humbled to initiate this Phase 2b/Phase 3 trial of AV-101, said Tim Noyes, Chief Executive Officer at Aerovate.
  • Starting enrollment represents an important milestone for Aerovate Therapeutics and advances our goal of improving the lives of patients suffering from rare cardiovascular diseases.
  • Aerovate expects to report top-line results from the Phase 2b portion of IMPAHCT in mid-2023.
  • IMPAHCT is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with pulmonary arterial hypertension (PAH) that will continuously enroll patients as the study progresses from Phase 2b to Phase 3.