Novartis has obtained FDA approval for Vijoice® (alpelisib) to treat severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in patients at least two years of age who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS.

• PROS describes a range of rare disorders caused by mutations of the PIK3CA The mutations lead to overgrowth in various parts of the body and can cause severe complications.
• Vijoice addresses the root cause of PROS by inhibiting the PIK3 pathway. The recommended dosing is 50mg once daily for pediatric patients and 250mg once daily for adults. Vijoice is taken by mouth with food.
• Novartis also markets alpelisib, the active pharmaceutical ingredient of Vijoice, under the brand name Piqray®. Piqray has been FDA approved since 2019 for use in combination with fulvestrant to treat males and postmenopausal females who have HR-positive, HER2-negative, PIK3CA- mutated advanced or metastatic breast cancer that has progressed on or after an endocrine- based regimen.
• The wholesale acquisition cost (WAC) for Vijoice is $32,500 per Each carton provides a 28- day supply of medication.