Approval marks a significant regulatory milestone for Adalvo's pulmonary arterial hypertension programme and demonstrates the company's scientific and regulatory expertise.
Zug, Switzerland, 24 September: Adalvo is pleased to announce the successful completion of the European Decentralised Procedure (DCP) for its Ambrisentan/Tadalafil fixed-dose combination (FDC), reaching End of Procedure (EoP) on 23 September 2026. This first-to-market FDC for pulmonary arterial hypertension (PAH) brings together two established therapies in a convenient once-daily regimen.
The approved DCP includes Ambrisentan/Tadalafil film-coated tablets in strengths of 5 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg. The fixed-dose combination brings together two established therapies for the treatment of PAH, a rare, progressive and life-threatening disease characterised by elevated blood pressure in the arteries of the lungs. By combining both active ingredients in a single tablet, the product has the potential to simplify treatment regimens and support improved patient convenience.
The global PAH treatment market is projected to reach approximately $13.3 billion by 2033, reflecting a CAGR of around 5.9% from 2026. This growth reflects increasing diagnosis rates, improved awareness and an expanding treatment landscape. According to IQVIA, combined global sales of Ambrisentan and Tadalafil exceeded $3 billion in 2025.
"Getting a highly complex FDC approved is a material success and a testament to Adalvo's scientific capabilities. As first generic FDC of Ambrisentan and Tadalafil, this approval represents an important achievement for our team and strengthens our ability to deliver complex, high-value pharmaceutical products to partners worldwide. We look forward to working with partners across Europe to bring this important treatment option to patients."
This DCP closure further strengthens Adalvo's specialty portfolio and demonstrates the company's ability to successfully navigate complex regulatory pathways across multiple European markets. With the regulatory milestone now achieved, Adalvo will focus on expanding commercial partnerships and supporting future launches across Europe.
Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force.