Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci® (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
July 26, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – CHMP, Johnson & Johnson, Johnson & Johnson Innovative Medicine, clinical trials, pulmonary arterial hypertension
If approved, Yuvanci® would become the only single tablet combination for treatment for patients with PAH
Johnson & Johnson’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment pathways
BEERSE, BELGIUM, July 26, 2024 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the Marketing Authorisation (MA) of Yuvanci®. Yuvanci® is a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg (M/T STCT) as a substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.1
PAH is a rare, progressive and life-threatening disease characterised by the constriction of small pulmonary arteries and elevated blood pressure (hypertension) in the pulmonary circulation that eventually leads to right heart failure and death.2,3 The 2022 European Society of Cardiology/European Respiratory Society (ESC/ERS) pulmonary hypertension (PH) guidelines have strengthened recommendations on initial double combination therapy with macitentan and tadalafil for PAH patients without cardiopulmonary comorbidities.4 However, this requires patients to take multiple pills as no single tablet that targets two or more PAH-specific pathways is available for these patients in Europe.
“PAH is a devastating disease affecting people of all ages and the burden the condition places on the daily lives of people living with it should not be underestimated,” 4,5 said Tamara Werner-Kiechle, M.D., EMEA Therapeutic Area Lead Neuroscience and Cardiopulmonary, Johnson & Johnson Innovative Medicine. “Bringing a single tablet combination follows the ESC/ERS guidelines, which recommend initial double and triple combination therapy,4 and could represent an important new option for adults living with PAH who face complex treatment regimens.” 6,7
The CHMP positive opinion for M/T STCT is based on data from the Phase 3 A DUE study. The A DUE study was a multi-national, multi-centre, double-blind, adaptive, randomised, active-controlled, parallel-group study in 187 adult patients with PAH (WHO FC II to III).8 The study was designed to compare the efficacy and safety of M/T STCT to each monotherapy, macitentan or tadalafil.8 The study met its primary endpoint, demonstrating change in pulmonary vascular resistance (PVR) expressed as the ratio of Week 16 to baseline in patients with PAH, for the comparison of M/T STCT versus the individual monotherapies.8
Treatment with M/T STCT resulted in a statistically significant effect of 0.71 (95% Confidence Interval [CI] 0.61, 0.82, p < 0.0001) representing a 29% reduction in PVR as compared to macitentan, and of 0.72 (95% CI 0.64, 0.80, p < 0.0001) representing a 28% reduction in PVR as compared to tadalafil.8 Consistent efficacy of M/T STCT on the primary endpoint was seen across subgroups of age, sex, race, and baseline WHO FC.1,8 Additionally, consistent efficacy was observed in patients who were either treatment-naïve, or previously exposed to an endothelin receptor antagonist (ERA) or phosphodiesterase type 5 inhibitor (PDE5i).8
The most common adverse events (AEs) (occurring in the M/T STCT-treated patients) from the combined double-blind/open-label A DUE study data were anaemia/haemoglobin decrease, oedema/fluid retention, and headache. The most common serious AE was anaemia, followed by palpitations, hypotension, intermenstrual bleeding, oedema/fluid retention and influenza.1
“Today’s positive opinion represents a significant step forward and underlines our commitment to providing solutions for patients in the PAH community,” said James F. List, M.D., Ph.D., Global Therapeutic Area Head, Cardiopulmonary, Johnson & Johnson Innovative Medicine. “We continue our commitment to transform PAH into a manageable condition and we look forward to working with health authorities to bring our single tablet combination therapy to adult patients in need across the region as soon as possible.”
Pending European Commission (EC) approval, Yuvanci® will be the only single tablet combination therapy in Europe for PAH. Approval by the EC will also mean J&J’s PAH portfolio will have the potential to cover all guideline-recommended treatment pathways. Today’s positive CHMP opinion follows the New Drug Application (NDA) approval of OPSYNVI® (macitentan and tadalafil) by the U.S. Food and Drug Administration (FDA) in March 2024 for the treatment of patients with PAH.9
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.janssen.com/emea. Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea.
