Ivacaftor Safe in CF Infants Aged 1 to 4 Months
A phase 3 clinical trial, ivacaftor (Kalydeco, Vertex Pharma) was generally safe to administer to infants aged 1-month to <4-months old, according to research published in Journal of Cystic Fibrosis.
Tag: ivacaftor Kalydeco
All
Latest
Ivacaftor Safe in CF Infants Aged 1 to 4 Months
A phase 3 clinical trial, ivacaftor (Kalydeco, Vertex Pharma) was generally safe to administer to infants aged 1-month to <4-months old, according to research published in Journal of Cystic Fibrosis.
Read More
Five Pharma Approvals from 2023
In some of the most notable pharmaceutical approvals from 2023, drugs for RSV, CF, COVID-19, sickle cell disease, and opioid overdose received an FDA stamp in 2023.
Read More
Health Canada OKs Ivacaftor for Cystic Fibrosis Patients Down to 2 Months
Health Canada granted market authorization for the expanded use of ivacaftor to treat cystic fibrosis in certain children ages 2 months and older.
Read More
FDA Grants Kalydeco Expanded Approval for Infants with Cystic Fibrosis
The medication now is approved for use in children with cystic fibrosis ages 1 month to less than 4 months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene.
Read More
Cystic Fibrosis: FDA Approves Kalydeco For Infants as Young as 4 Months
The US FDA has approved Kalydeco (ivacaftor, Vertex Pharma) as a therapy for cystic fibrosis in infants as young as 4 months old to less than 6 months old.
Read More
Survey: Cystic Fibrosis Patients Receiving CFTR Modulators Had More Positive Health Outlooks
Cystic fibrosis patients being treated with a CFTR modulator had more positive outlooks on their futures, treatment plans, and healthcare professionals.
Read More
Cystic Fibrosis: Ivacaftor May Reduce Common Lung Infections
Patients with cystic fibrosis who take ivacaftor (kalydeco) appear to have fewer respiratory infections over time than those not taking the drug.
Read MoreLong-term Kalydeco Use Preserved CF Patients’ Lung Function
New research points to long-term benefits for cystic fibrosis patients who were treated with Kalydeco (ivacaftor) for up to five years.
Read More
Kalydeco Approved for Kids 12-23 Months with Cystic Fibrosis
Kalydeco (ivacaftor) has been approved by the FDA for children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their CFTR gene.
Read More
More Positive Research on Long-term Benefits of Kalydeco
Vertex Pharmaceuticals data presented at the 41st European Cystic Fibrosis Conference supports the potential disease-modifying benefits of treating the underlying cause of CF.
Read MoreCF Children, Ages 1-2, Safely Treated with Kalydeco
Kalydeco (ivacaftor) was shown to be safe and well-tolerated in 1- and 2-year-old children with cystic fibrosis, based on data from a Phase 3 trial, Vertex Pharmaceuticals announced. Based on the positive interim results, Vertex...
Read MoreLatest Trial Data on Vertex CF Therapies and New Combos Show Benefits
Vertex Pharmaceuticals recently presented data from several clinical trials of cystic fibrosis treatments showing positive outcomes for CF patients. These findings were presented at the North American Cystic Fibrosis...
Read More
Hyperpolarized Helium MRI May Measure Kalydeco’s Effectiveness on CF
Researchers have developed an imaging technique using a specific form of helium to measure the effectiveness of ivacaftor (Kalydeco) on cystic fibrosis patients.
Read MoreFDA Investigates Benefits of Experimental Cystic Fibrosis Drug Over Kalydeco
The Food and Drug Administration (FDA) is questioning whether an experimental combination therapy for cystic fibrosis (CF) from Vertex Pharmaceuticals has any added benefits over Kalydeco.
Read MoreFDA OKs Kalydeco for Children Aged 2-5 with Cystic Fibrosis
The US FDA has expanded the approved use of Kalydeco for children aged two to five years with cystic fibrosis who have one of 10 mutations in their CFTR gene.
Read MoreArkansas Medicaid Settles Federal Lawsuit Over CF Drug Kalydeco
Arkansas Medicaid has settled a federal lawsuit brought by patients denied the cystic fibrosis (CF) drug Kalydeco due its high cost.
Read MoreFDA Approves Kalydeco for CF Patients with the R117H Mutation
Over 3,100 people in North America, Europe and Australia with the CF R117H mutation will have a new treatment option with the new Kalydeco approval.
Read MoreVertex Files for US and Europe Approval of Combination Drug for CF
Vertex’s pipeline combination lumacaftor-ivacaftor drug is indicated for the treatment of cystic fibrosis in patients carrying the F508del CFTR gene alteration.
Read MoreVertex Pharmaceuticals’ Kalydeco Wins FDA Panel Backing
An FDA Advisory Committee voted in favor of clearing Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco for an additional patient population.
Read More
Vertex CF Drug Combo Significantly Improves Lung Function
Vertex Pharmaceuticals Inc says results from two Phase 3 studies of its lumacaftor-ivacaftor drug combination showed statistically significant improvements in lung function (ppFEV1) in cystic fibrosis patients (12+) who have two copies of the F508del mutation.
Read MoreKalydeco Halves Loss of Lung Function in Cystic Fibrosis
Cystic fibrosis patients with the G551D mutation treated with Kalydeco (ivacaftor) reduced their annual loss of lung function by half over three years, compared to similar untreated CF patients.
Read MoreFDA Approves Expanded Kalydeco Use for Cystic Fibrosis
The FDA has approved a supplemental New Drug Application for Kalydeco (ivacaftor) for use in eight additional mutations that cause cystic fibrosis.
Read More
Kalydeco Wins The Wall Street Journal’s 2012 Technology Innovation Award
The drug, known to treat the underlying cause of cystic fibrosis, is recognized for having a wide impact in its field.
Read MoreVertex Expanding Studies of Kalydeco to More CF Patient Groups
The company announced plans to begin clinical trials of the potential cystic fibrosis therapy Kalydeco (VX-770) in more patient groups–including children as young as 2 years old–later this year.
Read More