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The European Medicines Agency's advisory group CHMP has adopted a position opinion backing the use of Vertex Pharmaceuticals' (NASDAQ:VRTX) Kalydeco (ivacaftor) in children as young as four months old (previously six months old) with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. It also backs its use in combination with tezacaftor in children as young as six years old (previously 12 years old) with CF who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T.A final decision from the European Commission usually takes ~60 days.
From Talk Markets