Factors Affecting the Price of Givinostat

The provided document focuses on the medical uses, dosage, and safety of Givinostat (Duvyzat) for Duchenne muscular dystrophy (DMD) but does not explicitly address pricing factors.

Factors Affecting the Price of Givinostat

However, broader pharmaceutical industry trends suggest key influences. As an orphan drug for a rare condition, Givinostat likely incurs high research and development (R&D) costs due to specialized clinical trials and limited patient pools . Its oral suspension formulation (8.86 mg/mL) requires specialized manufacturing and quality control, adding to production expenses . 

Regulatory exclusivity from orphan drug designations or patents may also allow higher pricing to offset investment risks. While the document emphasizes monitoring for adverse effects, these safety requirements could indirectly increase lifecycle management costs. Ultimately, pricing decisions for such niche therapies often balance clinical innovation with commercial sustainability, though specific financial details are not provided in the document.