SOUTH SAN FRANCISCO, CA, USA I September 30, 2020 I The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UPTRAVI® (selexipag) as an injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are currently prescribed oral UPTRAVI but are temporarily unable to take oral therapy. In patients with PAH, interruptions in treatment should be avoided due to the progressive nature of the disease.1
UPTRAVI is a selective, prostacyclin IP receptor agonist. Oral UPTRAVI was approved by the FDA in 2015 for the treatment of PAH to delay disease progression and reduce the risk of hospitalization.2
“Even relatively short-term PAH treatment interruptions due to a temporary inability to take oral medication, like during surgery, can have a significant negative impact on a person’s health,” said Neil Davie, Ph.D., Global Therapeutic Area Head, Pulmonary Hypertension, Janssen Research & Development, LLC. “We have demonstrated that continued treatment with UPTRAVI can significantly improve patients’ long-term outcomes. Preventing an interruption of treatment with an IV formulation is an important therapeutic option and we are pleased to be one step closer to bringing this important treatment to the PAH community.”
The NDA is based on the prospective, multi-center Phase 3 study designed to evaluate the safety and tolerability of patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose. Results showed that UPTRAVI IV is suitable to maintain continuous dosing for short periods of time when oral administration of UPTRAVI is not feasible.1
About the UPTRAVI IV Study1
The UPTRAVI IV study (NCT03187678) was a prospective, multi-center, open-label single-sequence cross–over, Phase 3 study designed to assess the safety, tolerability and pharmacokinetics of temporarily switching between oral UPTRAVI and UPTRAVI IV. The study examined a stable dose of UPTRAVI tablets to a corresponding dose of UPTRAVI for injection and switching back to UPTRAVI tablets. The treatment and observation phase was divided into 3 periods. In Period 1, patients received their stable oral dose of UPTRAVI twice daily (morning and evening of Day 1). In Period 2, patients received three infusions of corresponding UPTRAVI IV doses (morning and evening of Day 2, and morning of Day 3). In Period 3, patients resumed their stable oral UPTRAVI dose twice daily in the evening of Day 3 for 9 days, which was continued through the safety follow-up. Patients were hospitalized during Periods 1 and 2.
All 20 enrolled patients completed the study as planned and received all UPTRAVI doses (oral or IV). The switch between oral UPTRAVI and UPTRAVI IV was well tolerated, and there were no unexpected safety findings. Adverse reactions that resulted from UPTRAVI for injection were similar to those associated with UPTRAVI tablets, with the exception of infusion site reaction. Prostacyclin-associated adverse events included headache, diarrhea, nausea, vomiting, pain in jaw, myalgia, pain in extremity, flushing and arthralgia.1
IMPORTANT SAFETY INFORMATION2
INDICATION
UPTRAVI® (selexipag) is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
Effectiveness was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms.
Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), and PAH associated with congenital heart disease with repaired shunts (10%).
About Pulmonary Arterial Hypertension (PAH)
PAH is a specific form of PH that causes the walls of the pulmonary arteries (blood vessels leading from the right side of the heart to the lungs) to become thick and stiff, narrowing the space for blood to flow, and causing an increased blood pressure to develop within the lungs. PAH is a serious, progressive disease with a variety of etiologies and has a major impact on patients’ functioning as well as their physical, psychological and social wellbeing. There is currently no cure for PH and it is often fatal.3,4,5 However, the last decade has seen significant advances in the understanding of the pathophysiology of PAH, transforming the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10 years ago, to delayed disease progression today.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
References
- Data on file.
- UPTRAVI® (selexipag) Full Prescribing Information. Actelion Pharmaceuticals Ltd.
- Vachiéry JL, et al. Eur Respir Rev 2012;21:313-20.
- Galiè N, et al. Eur Heart J 2016;37:67-119.
- Hoeper MG, et al. Eur Respir Rev 2014;23:450-7.
SOURCE: Janssen Pharmaceutical Companies
Post Views: 32
SOUTH SAN FRANCISCO, CA, USA I September 30, 2020 I The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UPTRAVI® (selexipag) as an injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are currently prescribed oral UPTRAVI but are temporarily unable to take oral therapy. In patients with PAH, interruptions in treatment should be avoided due to the progressive nature of the disease.1
UPTRAVI is a selective, prostacyclin IP receptor agonist. Oral UPTRAVI was approved by the FDA in 2015 for the treatment of PAH to delay disease progression and reduce the risk of hospitalization.2
“Even relatively short-term PAH treatment interruptions due to a temporary inability to take oral medication, like during surgery, can have a significant negative impact on a person’s health,” said Neil Davie, Ph.D., Global Therapeutic Area Head, Pulmonary Hypertension, Janssen Research & Development, LLC. “We have demonstrated that continued treatment with UPTRAVI can significantly improve patients’ long-term outcomes. Preventing an interruption of treatment with an IV formulation is an important therapeutic option and we are pleased to be one step closer to bringing this important treatment to the PAH community.”
The NDA is based on the prospective, multi-center Phase 3 study designed to evaluate the safety and tolerability of patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose. Results showed that UPTRAVI IV is suitable to maintain continuous dosing for short periods of time when oral administration of UPTRAVI is not feasible.1
About the UPTRAVI IV Study1
The UPTRAVI IV study (NCT03187678) was a prospective, multi-center, open-label single-sequence cross–over, Phase 3 study designed to assess the safety, tolerability and pharmacokinetics of temporarily switching between oral UPTRAVI and UPTRAVI IV. The study examined a stable dose of UPTRAVI tablets to a corresponding dose of UPTRAVI for injection and switching back to UPTRAVI tablets. The treatment and observation phase was divided into 3 periods. In Period 1, patients received their stable oral dose of UPTRAVI twice daily (morning and evening of Day 1). In Period 2, patients received three infusions of corresponding UPTRAVI IV doses (morning and evening of Day 2, and morning of Day 3). In Period 3, patients resumed their stable oral UPTRAVI dose twice daily in the evening of Day 3 for 9 days, which was continued through the safety follow-up. Patients were hospitalized during Periods 1 and 2.
All 20 enrolled patients completed the study as planned and received all UPTRAVI doses (oral or IV). The switch between oral UPTRAVI and UPTRAVI IV was well tolerated, and there were no unexpected safety findings. Adverse reactions that resulted from UPTRAVI for injection were similar to those associated with UPTRAVI tablets, with the exception of infusion site reaction. Prostacyclin-associated adverse events included headache, diarrhea, nausea, vomiting, pain in jaw, myalgia, pain in extremity, flushing and arthralgia.1
IMPORTANT SAFETY INFORMATION2
INDICATION
UPTRAVI® (selexipag) is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
Effectiveness was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms.
Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), and PAH associated with congenital heart disease with repaired shunts (10%).
About Pulmonary Arterial Hypertension (PAH)
PAH is a specific form of PH that causes the walls of the pulmonary arteries (blood vessels leading from the right side of the heart to the lungs) to become thick and stiff, narrowing the space for blood to flow, and causing an increased blood pressure to develop within the lungs. PAH is a serious, progressive disease with a variety of etiologies and has a major impact on patients’ functioning as well as their physical, psychological and social wellbeing. There is currently no cure for PH and it is often fatal.3,4,5 However, the last decade has seen significant advances in the understanding of the pathophysiology of PAH, transforming the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10 years ago, to delayed disease progression today.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
References
- Data on file.
- UPTRAVI® (selexipag) Full Prescribing Information. Actelion Pharmaceuticals Ltd.
- Vachiéry JL, et al. Eur Respir Rev 2012;21:313-20.
- Galiè N, et al. Eur Heart J 2016;37:67-119.
- Hoeper MG, et al. Eur Respir Rev 2014;23:450-7.
SOURCE: Janssen Pharmaceutical Companies
Post Views: 32
