Adalvo has successfully completed the fixed-dose combination development of Ambrisentan + Tadalafil film-coated tablets and is set to proceed with DCP submission this February, marking a key step towards addressing critical gaps in Pulmonary Arterial Hypertension (PAH) treatment.
As the first-ever fixed-dose combination (FDC) of Ambrisentan and Tadalafil for PAH, this oral once-daily treatment provides a differentiated approach, significantly reducing the risk of clinical failure events compared to monotherapy. By uniting these two proven active substances, the therapy has demonstrated superior efficacy over monotherapies, as validated by the AMBITION study sponsored by GlaxoSmithKline and Gilead Sciences.
With the PAH market projected to reach $11 billion by 2030, the demand for added-value therapies continues to grow. In 2023 alone, Ambrisentan and Tadalafil brands generated a combined $1 billion in global sales (IQVIA), highlighting the strong need for advanced treatment options.
With launch in Europe expected upon approval, Adalvo invites partners and stakeholders to stay informed about this milestone and upcoming developments.
Connect with us today to explore potential collaborations and bring this therapy to patients worldwide.