Summary of the risk management plan (RMP) for Orkambi (lumacaftor and ivacaftor)

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1 EMA/662624/2015 Summary of the risk management plan (RMP) for Orkambi (lumacaftor and ivacaftor) This is a summary of the risk management plan (RMP) for Orkambi, which details the measures to be taken in order to ensure that Orkambi is used as safely as possible. For more information on RMP summaries, see here. This RMP summary should be read in conjunction with the EPAR summary and the product information for Orkambi, which can be found on Orkambi s EPAR page. Overview of disease epidemiology Orkambi is a medicine used to treat cystic fibrosis in patients aged 12 years and above who have a genetic mutation called the F508del mutation. This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR) which is involved in regulating the production of mucus and digestive juices. Orkambi is used in patients who have inherited the mutation from both parents and therefore have the mutation in both copies of the CFTR gene. Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system. It affects the cells that produce mucus and digestive juices. In cystic fibrosis, the secretions become thick and cause blockage. Build-up of thick and sticky secretions in the lungs causes inflammation and longterm infection. In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth. Cystic fibrosis affects approximately 70,000 people worldwide. More than 1,900 types of CFTR mutations have been reported to date, with F508del being the most frequent mutation. Across 22 countries in Europe, about 43% of patients with cystic fibrosis are estimated to have 2 copies of F508del mutation. About 49% of patients with cystic fibrosis in the US and Europe are 18 years of age or older. About 52% of patients in the US and Europe are male. Cystic fibrosis affects all racial and ethnic groups and is more common among Caucasians. A patient with cystic fibrosis born in the last 2 decades of the 20th century (in an economically developed nation) is expected to have a greater-than-50% chance of survival to 40 years of age. The median age at death of patients with cystic fibrosis varies from 25 to 32 years across the developed countries. Summary of treatment benefits Orkambi contains the active substances lumacaftor and ivacaftor. Orkambi was shown to be effective at improving lung function in two main studies involving 1,108 patients with cystic fibrosis aged 12 years and above who had the F508del mutation in both copies of the CFTR gene. In the studies, Orkambi was compared with placebo (a dummy treatment), both added to patients usual therapy. The Page 1/7

2 main measure of effectiveness was based on improvement in patients percent of predicted FEV 1 which is a measure of how well the lungs work. Results from the first study showed that after 24 weeks of treatment patients who took Orkambi had an average improvement in FEV 1 of 2.41 percentage points more than those who took placebo, whereas this figure was 2.65 in the second study. Treatment with Orkambi also led to a reduction in the number of exacerbations (flares-up) requiring hospital admission or antibiotic therapy. Overall the number of exacerbations was reduced by 39% when compared with placebo. Unknowns relating to treatment benefits Information on long-term use of Orkambi is not available and data gathered over up to 120 weeks (2.3 years) will be investigated in an ongoing long-term study. The efficacy and safety of Orkambi have not been established in patients with cystic fibrosis under the age of 12 years; however, studies are planned to evaluate Orkambi in patients under the age of 12 years who have two copies of the F508del mutation. Summary of safety concerns Important identified risks Risk Preventability Respiratory events (events affecting the airways) Some respiratory events (e.g. chest tightness and shortness of breath) were observed with Orkambi treatment. Most of these events were mild or moderate in severity and did not require discontinuation of Orkambi treatment. Only five patients treated with Orkambi in clinical studies discontinued treatment due to respiratory events. These events mostly occurred during the first week of treatment and resolved within a few days without a need to change the dose of Orkambi. Respiratory events occurred more frequently in patients with poorer lung function but the severity of these events was similar regardless of how poor lung function was. In patients with poor lung function (percent predicted FEV 1 < 40%) experience is limited and patients should be closely monitored when starting treatment with Orkambi. Orkambi should also not be started during pulmonary exacerbations (temporary worsening of the lung function due to an infection or inflammation) as there is no experience in this group of patients. Important potential risks Risk (liver-related events) Raised levels of liver enzymes called transaminases (ALT or AST) or liverrelated side effects were reported in clinical studies with Orkambi. These events occurred in similar proportions in patients who received Orkambi and placebo; however, more patients receiving Orkambi had serious liver-related Page 2/7

3 Risk side effects. Raised levels of ALT or AST associated with increases in total bilirubin concentrations occurred in 0.4% of patients treated with Orkambi. These elevations could be a sign of liver injury. Seven patients who received Orkambi in clinical studies already had advanced liver disease. In one patient, liver function worsened after receiving Orkambi and only recovered after Orkambi was stopped. The risk is considered potential because elevations in transaminases are common in patients with cystic fibrosis and the role of Orkambi is unclear. A study in patients with moderate liver impairment showed that blood levels of lumacaftor and ivacaftor increased in these patients. Studies have not been conducted in patients with severe liver impairment; however, it is expected that blood levels of lumacaftor and ivacaftor may increase more than in patients with moderate liver impairment. Orkambi with strong CYP3A inhibitors or inducers Use of Orkambi with CYP3A substrates and CYP3A substrates with a narrow therapeutic index (substances broken down by the enzyme CYP3A, particularly if the substance s effects increase greatly with just a small increase in blood level) Cataracts (clouding of the lens in the eye that affects vision) (irregular heartbeats) Off-label use in children less than 12 years of age or in Ivacaftor is broken down in the body by an enzyme called CYP3A. Taking Orkambi with medicines which block this enzyme (also called inhibitors) can increase the level of ivacaftor in the blood and therefore its side effects. Taking Orkambi with medicines which increase the activity of the enzyme CYP3A (also called inducers) can decrease the level of ivacaftor in the blood and possibly make it less effective. Using Orkambi with strong CYP3A inhibitors or inducers could adversely influence how well Orkambi works or may increase its side effects. This risk is considered potential because such an interaction has not been reported in humans so far, despite biologic plausibility. Orkambi can decrease the level of some medicines that are broken down by an enzyme called CYP3A; this may decrease the effects of these medicines. This risk is considered potential because such an interaction has not been reported in humans so far, despite biologic plausibility. Cataracts occurred in a study in juvenile rats given ivacaftor. In the ivacaftor programme, there have been reports of non-congenital lens abnormalities in patients. All reported events involved subtle findings and had no impact on vision. The relationship to ivacaftor is uncertain because of the presence of other possible causes; therefore, the risk is considered potential. The important potential risk of irregular heartbeat is based on theoretical considerations and studies in dogs. In clinical trials irregular heartbeat was reported in patients who received Orkambi but they were few and occurred in similar proportions in the placebo group. The majority was non-serious. On this basis, the risk is considered potential. Orkambi is indicated only in patients who are aged 12 years or older and have 2 copies of the F508del gene. Orkambi has not been proved to be effective in patients younger than 12 years or in patients with other CFTR mutations. Page 3/7

4 Risk patients who are not homozygous for F508del-CFTR mutation (children who do not have the F508del mutation in both copies of the CFTR gene) Missing information Risk Use in pregnant and breastfeeding women predicted FEV 1 <40% Long-term safety Safety in patients with cardiac (heart) diseases Use in patients with organ transplant Effect of Orkambi on medicines known as P-glycoprotein (P-gp) substrates Potential off-target activity (unintended effect) of M6-ivacaftor (main metabolite of ivacaftor) Interaction potential between transporters As a standard precautionary measure, pregnant and breastfeeding women were excluded from clinical studies. However, animal studies suggest that Orkambi does not cause malformations or birth defects in the fetuses of rats and rabbits. Patients with more severely reduced lung function (percent predicted FEV 1 lower than 40) were excluded from clinical studies; however, the safety of Orkambi was studied in 81 of these patients. Overall, Orkambi was well tolerated in these patients. The most common side effects were common symptoms of cystic fibrosis such as breathing difficulty which occurred at a higher rate than in patients with less severely reduced lung function. Data for Orkambi are available for up to 48 weeks of treatment and results showed that Orkambi treatment is well tolerated. Orkambi has not been studied in patients with heart disease. However, irregular heartbeat has been reported in clinical trials but it occurred in similar proportions in patients who received Orkambi and placebo. The risk of Orkambi treatment in patients with heart diseases is based on theoretical considerations and on animal studies with unknown relevance to humans. Orkambi has not been studied in patients with cystic fibrosis who have had an organ transplant. Therefore, use in such patients is not recommended. Orkambi can change the blood levels of medicines known as P-gp substrates (medicines that are transported in the body by a protein called P-gp). Although some in vitro data is available, in vivo studies on this interaction were not performed. In particular, in vitro studies are available that have shown that lumacaftor can either increase or decrease the blood levels of these medicines. In addition, a clinical study showed that ivacaftor is a weak inhibitor of P-gp. With Orkambi (lumacaftor/ivacaftor) treatment, the patient receives a higher dose of ivacaftor (250 mg every 12 hours) compared with ivacaftor used alone (150 mg every 12 hours). Therefore, the blood level of M6-ivacaftor (a metabolite of ivacaftor) was higher in Orkambi treatment. Although Orkambi has been well tolerated in clinical studies, the activity of M6-ivacaftor in the body is not completely known at this time. The interaction potential between transporter proteins such as BCRP, MRP2, OAT1, OAT3, OCT1, and OCT2 and Orkambi is unknown. Inhibition of these Page 4/7

5 Risk and Orkambi Environmental risk transporters could change the levels of medicines which use these transporter systems. The means of removing Orkambi from the body are not completely understood and transporters such as BCRP and MRP2 may be involved. Data on the potential for Orkambi to affect the environment are incomplete at this time. Summary of risk minimisation measures by safety concern All medicines have a summary of product characteristics (SmPC) which provides physicians, pharmacists and other healthcare professionals with details on how to use the medicine, and also describes the risks and recommendations for minimising them. Information for patients is available in lay language in the package leaflet. The measures listed in these documents are known as routine risk minimisation measures. The SmPC and the package leaflet are part of the medicine s product information. The product information for Orkambi can be found on Orkambi s EPAR page. This medicine has no additional risk minimisation measures. Planned post-authorisation development plan Study/activity (including study number) Objectives Safety concerns /efficacy issue addressed Status Planned date for submission of (interim and) final results Study 105 A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Longterm Treatment With LUM/IVA (lumacaftor and ivacaftor) in Subjects Aged 12 Years and Older With CF, Homozygous or Heterozygous for the F508del-CFTR Mutation To evaluate the long-term safety and efficacy of LUM/IVA in subjects with cystic fibrosis (CF) Respiratory events LUM/IVA with strong CYP3A inhibitors or inducers LUM/IVA with sensitive CYP3A substrates and CYP3A substrates with a narrow therapeutic index Cataracts predicted FEV1 <40% Started December 2016 Long-term safety Safety in patients with cardiac diseases Page 5/7

6 Study/activity (including study number) Objectives Safety concerns /efficacy issue addressed Status Planned date for submission of (interim and) final results Study 106 A Phase 3b, Open-Label Study to Evaluate LUM/IVA Therapy in Subjects 12 Years and Older With CF and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation To provide LUM/IVA therapy to subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del mutation on the CFTR gene Respiratory events LUM/IVA with strong CYP3A inhibitors or inducers LUM/IVA with sensitive CYP3A substrates and CYP3A substrates with a narrow therapeutic index Started March 2017 Cataracts predicted FEV1 <40% Safety in patients with cardiac diseases Study 108 (PASS) An Observational Study to Evaluate the Utilisation Patterns and Long-Term Effects of LUM/IVA Therapy in Patients with CF To evaluate the long-term safety of LUM/IVA in patients with CF Off-label use Use in pregnant women predicted FEV1<40% Long-term safety Planned Annual Reports: December 2017/2018/2019/ 2020 December 2021 Safety in patients with cardiac diseases Use in patients with organ transplant Study An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years or Younger With CF To evaluate the prevalence and progression of cataracts in paediatric patients on ivacaftor alone Cataracts Started December 2016 Page 6/7

7 Study/activity (including study number) Objectives Safety concerns /efficacy issue addressed Status Planned date for submission of (interim and) final results Nonclinical Nonclinical studies to evaluate the potential off-target activity (receptor binding and ion channel activity) of M6-ivacaftor Potential off-target activity of M6-ivacaftor Planned June 2016 Nonclinical In vitro studies to evaluate the potential inhibition of BCRP, OAT1, OAT3, OCT1, and OCT2 by lumacaftor and/or ivacaftor, and to evaluate if lumacaftor is a substrate for BCRP and MRP2 Interaction potential between transporters and lumacaftor and/or ivacaftor Planned December 2015 Nonclinical Nonclinical studies to evaluate potential environmental risk for lumacaftor and ivacaftor Environmental risk Ongoing Updated ERA Report: December 2015 List of studies in post-authorisation development plan None. Studies which are a condition of the marketing authorisation There are no studies that are a condition of the marketing authorisation. This summary was last updated in Page 7/7

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