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Vijoice FDA Approval History

Last updated by Judith Stewart, BPharm on April 7, 2022.

FDA Approved: Yes (First approved April 5, 2022)
Brand name: Vijoice
Generic name: alpelisib
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: PIK3CA-Related Overgrowth Spectrum

Vijoice (alpelisib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

  • The U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice, and in accordance with the Accelerated Approval Program, continued approval may be contingent upon verification and description of clinical benefit from confirmatory evidence.
  • PROS is a spectrum of rare conditions and is characterized by atypical overgrowths and anomalies in blood vessels, the lymphatic system and other tissues.
  • Vijoice is first approved treatment to specifically address the root cause of PROS conditions. Approval was based on real-world data from EPIK-P1 study, which showed patients treated with Vijoice experienced reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms.
  • Vijoice works by inhibiting the PI3K pathway to treat the overgrowth conditions caused by the effects of PIK3CA mutations in adults and children with PROS.
  • Vijoice is administered orally once daily with food.
  • Vijoice is associated with the following warnings and precautions: severe hypersensitivity reactions, severe cutaneous adverse reactions (SCARs), hyperglycemia, pneumonitis, diarrhea, and embryo-fetal toxicity.
  • Common adverse reactions include diarrhea, stomatitis, and hyperglycemia.

Development timeline for Vijoice

Apr  6, 2022Approval FDA Approves Vijoice (alpelisib) for the Treatment of PIK3CA-Related Overgrowth Spectrum (PROS)
Sep 17, 2021Novartis Announces Findings From a Real-World Study of Alpelisib Demonstrating Clinical Benefit in People with PIK3CA-Related Overgrowth Spectrum (PROS)

Further information

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