Rapharma has brought to market Tadaleаr (tadalafil) for the treatment of PAH of WHO functional class II–III in adults (from age 18) and in children and adolescents aged 2 to 18. It is the company’s second drug for the orphan condition, following Bozenex (bosentan). In this way, the company is expanding treatment options for rare diseases by building PAH-specific therapy with drugs from two key classes.
The drug is available in film-coated tablets of 20 mg, pack size 28. It is used to improve exercise tolerance.
The active ingredient of Tadaleаr, tadalafil, belongs to phosphodiesterase type 5 (PDE5) inhibitors. By suppressing PDE5 activity, the drug relaxes and dilates the pulmonary artery, achieving sustained reduction in pulmonary vascular resistance. According to Russian and international clinical guidelines, tadalafil can be used as monotherapy or in combination with endothelin receptor antagonists (bosentan, macitentan, ambrisentan).
Based on comparative pharmacokinetics and bioequivalence studies, Tadaleаr is fully consistent with the original tadalafil.
Pulmonary arterial hypertension is a severe, progressive orphan disease of the pulmonary circulation, characterised by elevated mean pulmonary artery pressure. Without specific therapy, it leads to progressive decline in exercise tolerance, deterioration of quality of life, development of heart failure and death.
