Alpelisib-Piqray trial to treat excessive blood vessel growth

Alpelisib (Alpelisib) - another brand of Piqray Vijoice, 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) requiring systemic therapy. PROS is a rare disease characterized by atypical growths and abnormalities in blood vessels, lymphatic system, and other tissues. Vijoice is the first approved treatment to specifically address the root cause of PROS conditions.

The FDA approval was based on real-world evidence from EPIK-P1, a retrospective chart review study that showed reductions in target lesion volume and improvements in PROS-related symptoms and performance in patients treated with Apelvis. Analysis of the primary endpoint at week 24 showed that 27% of patients achieved a confirmed response to treatment, defined as a 20% or greater reduction in the sum of PROS target lesion volumes. Nearly three-quarters (74%) of patients who underwent imaging at baseline and week 24 had a reduction in target lesion volume, with an average reduction of 13.7%, and no patients had progressive disease at the time of the preliminary analysis. Additionally, at week 24, researchers observed improvements in pain, fatigue, vascular malformations, limb asymmetry, and disseminated intravascular coagulation. These improvements were observed in a subset of patients in the study population who reported symptoms at baseline and Week 24.

The original drug of Apellis is not marketed in the country and therefore cannot be included in medical insurance. There are European and Indian versions of the original Apelvis drug sold overseas. The ingredients are basically the same. The price of the European version of 150mg*56 tablets per box may be more than 4 RMB 40,000 ( (The price may fluctuate due to the exchange rate), The price of the Indian version150mg*28 tablets per box may be more than 5,000 yuan (the price may fluctuate due to the exchange rate). There are currently no generic versions of Apelvis produced available on the market.