Two Phase 3 Studies of the Tezacaftor/Ivacaftor Combination Treatment Met Primary Endpoints with Statistically Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis. Study in people who have two copies of the F5. FEV1 of 4. 0 percentage points compared to placebo (p < 0. Study in people who have one mutation that results in residual CFTR function and one F5. FEV1 of 6. 8 percentage points with the tezacaftor/ivacaftor combination treatment compared to placebo (p < 0.
Across both studies, the combination treatment was generally well tolerated- -Vertex to host investor conference call tomorrow at 8: 0. EDT- BOSTON- -(BUSINESS WIRE)- - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from two Phase 3 studies of the tezacaftor (VX- 6. FEV1) in people with cystic fibrosis (CF) ages 1. CFTR) gene. The 2. EVOLVE study evaluated the combination treatment in people who have two copies of the F5.
This study met its primary endpoint with a mean absolute improvement in pp. FEV1 through 2. 4 weeks of 4. The second study, EXPAND, was an 8- week crossover study that evaluated the combination treatment in people who have one mutation that results in residual CFTR function and one F5. This study met the primary endpoints of absolute change in pp.
FEV1 from baseline to the average of the Week 4 and Week 8 measurements, with the tezacaftor/ivacaftor combination treatment demonstrating a mean absolute improvement of 6. Based on these results, Vertex plans to submit a New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the third quarter of 2. CF ages 1. 2 and older who have two copies of the F5. CFTR function and F5. Vertex will host a conference call for investors tomorrow, March 2. EDT, to discuss these results.
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The most common adverse events, regardless of treatment group, were infective pulmonary exacerbation and cough. In both studies, rates of discontinuations due to adverse events were low and similar between placebo and treatment groups (2. Rates of respiratory adverse events were similar between placebo and treatment groups (1. The combination group received tezacaftor 1. QD) in combination with ivacaftor 1.
In the study, more than 5. North America and Europe. The primary endpoint was absolute change in pp. FEV1 from baseline through Week 2. The mean pp. FEV1 at baseline was approximately 6. Of the 4. 77 people who completed the 2. Efficacy Results.
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Primary Endpoint: Through 2. FEV1 was 4. 0 percentage points from baseline for those treated with the tezacaftor/ivacaftor combination compared to placebo (p < 0.
The majority of adverse events were mild or moderate. The most common adverse events (. The rate of discontinuations due to adverse events was low and similar between the placebo group and the combination treatment group. Rates of adverse events, serious adverse events and respiratory- related adverse events were similar between the placebo and the tezacaftor/ivacaftor combination treatment groups. Patients were randomized to one of six treatment groups to receive tezacaftor/ivacaftor, ivacaftor monotherapy or placebo for eight weeks, followed by an 8- week washout period. Following the washout period, patients switched to one of the other two treatment regimens for another eight weeks.
The combination treatment group evaluated tezacaftor 1. QD) in combination with ivacaftor 1. In the study, approximately 2. North America and Europe. The primary endpoints were absolute change in pp. FEV1 from baseline to the average of the Week 4 and Week 8 measurements for each of the treatment groups (tezacaftor/ivacaftor combination treatment and ivacaftor monotherapy) compared to placebo. The mean pp. FEV1 at baseline was approximately 6.
Of the 2. 35 people who completed the study, 2. Efficacy Results. Lung Function: The mean absolute improvement in pp.
FEV1 was 6. 8 percentage points from baseline compared to placebo (p < 0. An additional pre- specified analysis of the combination group compared to the monotherapy group showed that the tezacaftor/ivacaftor combination treatment provided a statistically significant improvement in pp. FEV1 over the use of ivacaftor alone (2. CFQ- R: The key secondary endpoint was absolute change in the Cystic Fibrosis Questionnaire- Revised (CFQ- R) respiratory domain score from baseline to the average of the Week 4 and Week 8 measurements for each of the treatment groups (tezacaftor/ivacaftor combination treatment and ivacaftor monotherapy) compared to placebo. The tezacaftor/ivacaftor combination treatment as well as ivacaftor monotherapy were both generally well tolerated. The majority of adverse events were mild or moderate.
The most common adverse events (. There were no discontinuations due to adverse events in the combination treatment group. Discontinuations due to adverse events were low and similar between the placebo group and the ivacaftor monotherapy group. The incidence of adverse events, serious adverse events and respiratory- related adverse events was similar between the placebo, tezacaftor/ivacaftor combination and ivacaftor monotherapy groups. INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO. KALYDECO is not for use in people with CF due to other mutations in the CF gene.
KALYDECO is not effective in patients with CF with two copies of the F5. F5. 08del/F5. 08del) in the CF gene. It is not known if KALYDECO is safe and effective in children under 2 years of age. Patients should not take KALYDECO if they are taking certain medicines or herbal supplements such as: the antibiotics rifampin or rifabutin; seizure medications such as phenobarbital, carbamazepine, or phenytoin; or St. John's wort. Before taking KALYDECO, patients should tell their doctor if they: have liver or kidney problems; drink grapefruit juice, or eat grapefruit or Seville oranges; are pregnant or plan to become pregnant because it is not known if KALYDECO will harm an unborn baby; and are breastfeeding or planning to breastfeed because is not known if KALYDECO passes into breast milk.
KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works. Therefore the dose of KALYDECO may need to be adjusted when taken with certain medications.
Patients should especially tell their doctor if they take antifungal medications such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin. Patients should not drive a car, use machinery, or do anything that needs them to be alert until they know how KALYDECO affects them. Patients should avoid food containing grapefruit or Seville oranges while taking KALYDECO. KALYDECO can cause serious side effects including: High liver enzymes in the blood have been reported in patients receiving KALYDECO.
The patient's doctor will do blood tests to check their liver before starting KALYDECO, every 3 months during the first year of taking KALYDECO, and every year while taking KALYDECO. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber- colored urine.
The patient's doctor should perform eye examinations prior to and during treatment with KALYDECO to look for cataracts. The most common side effects include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness. Please click here to see the full Prescribing Information for KALYDECO (ivacaftor). About CF. CF is a rare, life- shortening genetic disease affecting approximately 7.
North America, Europe and Australia. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,0. CFTR gene. Some of these mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non- working or too few CFTR protein at the cell surface. The defective function or absence of CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the mid- to- late 2.
Tezacaftor is designed to address the processing defect of F5. CFTR to enable it to reach the cell surface where ivacaftor can further enhance the protein's function. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life- threatening diseases. For seven years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.
Collaborative History with Cystic Fibrosis Foundation Therapeutics, Inc. Chodakewitz's statements in the third paragraph, and the information provided regarding Vertex's plans to submit regulatory applications for tezacaftor/ivacaftor combination treatment, including a New Drug Application (NDA) in the United States and Marketing Authorization Application (MAA) in Europe, in the third quarter of 2.
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FRM averaged 2. 7. Treasury- indexed hybrid adjustable- rate mortgage (ARM) averaged 3. A year ago at this time, the 5- year ARM averaged 2.
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