Participants were randomly assigned to receive Trikafta or placebo based on age and weight: Aged 6 to <12 years and less than 30kg: morning dose of elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg ...
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA ® (elexacaftor ...
Vertex Pharmaceuticals (VRTX) announced the U.S. Food and Drug Administration has approved the expanded use of Trikafta for the treatment of people with cystic fibrosis ages 2 and older who have ...
The drug is also eligible for use in CF patients who have discontinued Trikafta or Vertex’s other CF medicines. Similar regulatory filings are also under review in Europe. However, the drug’s ...
FDA approval of ALYFTREK and TRIKAFTA expands CF treatment options to over 300 mutations, benefiting 300 newly eligible U.S. patients. Suzetrigine for acute pain aligns with NOPAIN Act ...
The approval also helps shield from erosion of sales when Trikafta loses its patent, said William Blair analyst Myles Minter ahead of the decision. Cystic fibrosis is an inherited disease in which ...