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Research | CFTR Modulators | Drug Pipeline CF Foundation Celebrates FDA Approval of Triple Combination

The U.S. Food and Drug Administration has approved the use of the triple-combination modulator elexacaftor/tezacaftor/ivacaftor (Trikafta™) for people with cystic fibrosis ages 12 and older who have at least one copy of the F508del mutation.

| 3 min read
Research | CFTR Modulators | Drug Pipeline FDA Expands Use of Orkambi® to Children With CF Ages 2 to 5

The U.S. Food and Drug Administration approved the use of lumacaftor/ivacaftor (Orkambi®) today for children with cystic fibrosis ages 2 to 5 who have two copies of the F508del mutation.

| 3 min read
CFTR Modulators Positive Early Study Results for Next-Generation CFTR Modulators

New data show positive results in individuals with a single F508del mutation as well as people with two copies of F508del and support continued development of triple combination therapies. 

| 6 min read
Research | CFTR Modulators | Drug Pipeline FDA Approves Ivacaftor for 23 Additional CFTR Mutations

The U.S. Food and Drug Administration (FDA) today approved ivacaftor (Kalydeco®) for people ages 2 and older who have at least one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

| 3 min read
About the CF Foundation | CFTR Modulators FDA Expands Use of Orkambi® to Children Ages 6 to 11 With CF

The U.S. Food and Drug Administration (FDA) approved the use of lumacaftor/ivacaftor (Orkambi®) today for children with cystic fibrosis ages 6 to 11, who have two copies of the F508del mutation.

| 2 min read
CFTR Modulators FDA Does Not Approve Ivacaftor for Some Rare Mutations of Cystic Fibrosis

The U.S. Food and Drug Administration (FDA) has decided not to approve the use of ivacaftor (Kalydeco®) to treat people with cystic fibrosis ages 2 and older who have one of 23 rare CF mutations, known as “residual function” mutations. 

| 2 min read
About the CF Foundation | CFTR Modulators CF Therapy Orkambi Approved in Europe

The European Commission has approved the cystic fibrosis drug Orkambi® for people with two copies of the F508del mutation ages 12 and older in the European Union.

| 2 min read
Research | CFTR Modulators CF Foundation Celebrates FDA Approval of Orkambi as Important Advance for the CF Community

The Cystic Fibrosis Foundation celebrates the FDA's approval today of the lumacaftor/ivacaftor combination drug (Orkambi™) as an important advance for the cystic fibrosis community. Orkambi targets the underlying cause of the disease in people with two copies of the most common CF gene mutation.

| 4 min read
About the CF Foundation | CFTR Modulators Letter to the Community on Orkambi Approval

Today we received the exciting news that the U.S. Food and Drug Administration has approved Orkambi for people with cystic fibrosis ages 12 and older who have two copies of the F508del gene mutation, the most common CF mutation.

| 2 min read
About the CF Foundation | CFTR Modulators FDA Approves Ivacaftor for People with R117H Mutation of Cystic Fibrosis

The U.S. Food and Drug Administration (FDA) announced today that it has approved the use of ivacaftor (Kalydeco™) to treat people with cystic fibrosis ages 6 and older who have the R117H mutation.

| 2 min read