Novartis Receives the CHMP Positive Opinion of Vijoice for PROS Disorders 

Shots: 

• The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy 

• EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based primarily on imaging scans. At 24 wks, 37.5% of pts (12 of 32) responded to Vijoice treatment 

• Vijoice will be available as 50 mg, 125 mg, and 200 mg film-coated tablets, and 50 mg granules. Alpelisib is a PI3K inhibitor that reduces abnormal tissue growth by blocking PI3K enzyme activity 

Ref: EMA| Image: Novartis |Press Release

Related News: Boehringer Ingelheim Receives the CHMP Positive Opinion of Jascayd for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) 

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