Symkevi

June 25, 2019June 25, 2019

FDA Approves Symdeko for Treatment of CF Children, Ages 6 to 11, with Certain CFTR Mutations

News

The U.S. Food and Drug Administration (FDA) has approved Symdeko (tezacaftor/ivacaftor and ivacaftor) tablets for the treatment of children, ages 6 to 11 years, with cystic fibrosis (CF) who ... Read more

February 18, 2019February 28, 2019

Vertex Plans to Ask for Extended Approval of Symkevi in Europe for CF Children Ages 6-11

cystic fibrosis, News

Results from a Phase 3 trial demonstrate that Symkevi (tezacaftor and ivacaftor combo), known as Symdeko in the U.S., is safe and can effectively improve lung clearance in children, ... Read more

November 2, 2018November 2, 2018

Symkevi Approved in EU for CF Patients with Two F508del Mutations, or One Plus a Minimal Function Mutation

cystic fibrosis, News

Symkevi (tezacaftor/ivacaftor combo), by Vertex Pharmaceuticals, has been approved in the European Union for patients with cystic fibrosis (CF) ages 12 or older who carry F508del mutations. Importantly, the European Commission’s decision to grant marketing ... Read more

October 3, 2018October 3, 2018

Agreement Readies Denmark, Austria for Approval of Vertex CF Therapies

cystic fibrosis, News

Vertex Pharmaceuticals has entered a partnership with the Danish pharmaceutical organization Amgros to one day make Vertex’s cystic fibrosis (CF) therapies available for Danish patients. The collaboration was made through ... Read more

July 30, 2018July 30, 2018

European Committee Recommends Approval of Vertex’s Combo Therapy Symkevi for Certain CF Patients

cystic fibrosis, News

Vertex Pharmaceuticals’ Symkevi (tezacaftor/ivacaftor) is one step closer to being approved in the European Union as a treatment for cystic fibrosis (CF) patients ages 12 or older who have ... Read more

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