Taiwan-based international pharmaceutical company Lotus Pharmaceutical announced yesterday that its drug Adcirca (Tadalafil) has received approval from the Taiwan Food and Drug Administration (TFDA) for the treatment of pulmonary arterial hypertension (PAH).

PAH is a rare and progressive disease with no known cure. According to the 2022 European Society of Cardiology (ESC) / European Respiratory Society (ERS) treatment guidelines, Tadalafil is the only Class I recommended therapy for PAH and should be used in combination with endothelin receptor antagonists (ERAs) as first-line treatment. Previously, since Tadalafil had not been approved for PAH in Taiwan, cardiologists could only prescribe another PDE5 inhibitor, which has weaker supporting evidence for combination therapy.

Between 2014 and 2023, Taiwan’s PAH-PDE5 inhibitor market grew from NT$1.3 billion to over NT$4 billion, indicating significant growth potential for Adcirca. With its approval, Taiwanese patients can now benefit from a strongly recommended international treatment option, along with the convenience of once-daily dosing, improving their overall quality of life.

Petar Vazharov, CEO of Lotus Pharmaceutical, expressed his excitement about bringing Adcirca to Taiwan, providing PAH patients with a new treatment option and renewed hope. He emphasized that this approval reaffirms Lotus Pharmaceutical’s commitment to delivering high-quality, safe, and accessible medications, ensuring that patients receive the most appropriate treatment available.

Resource: 美時藥品Adcirca獲TFDA核准用於治療肺動脈高壓