NEW YORK, NY, USA I June 28, 2019 I Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the efficacy and safety of intravenous (IV) sildenafil when added to inhaled nitric oxide (iNO) for the treatment of newborns with Persistent Pulmonary Hypertension (PPHN) did not meet its primary efficacy endpoint. Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. Sildenafil is not indicated for the treatment of PPHN. The study was part of an EU Pediatric Investigational Plan (PIP).
About the Study
This Phase 3 study had two consecutive parts: Part A is the randomized, placebo-controlled, double-blind interventional phase to assess efficacy and safety; and Part B is the non-interventional phase with follow-up at 12 and 24 months after the end of study treatment to evaluate developmental progress. These results solely pertain to the outcomes observed from Part A of the study; Part B is ongoing. The co-primary endpoints are treatment failure rate, defined as need for additional PPHN treatment, need for extracorporeal membrane oxygenation1 (ECMO), or death during the study; and time on iNO treatment after initiation of IV study drug for subjects without treatment failure.
The safety and adverse event profile observed in this study was comparable to the known safety profile of Revatio in prior studies in pediatric and adult patients with pulmonary arterial hypertension taking Revatio. Most adverse events were of mild to moderate severity and were consistent with the known pharmacology of phosphodiesterase-5 inhibitors, the class of medications to which Revatio belongs. The benefit-risk profile of Revatio remains favorable for the approved indications when used in accordance with the approved label.
About Pulmonary Hypertension and PPHN
Pulmonary hypertension (PH) is an incurable and life-threatening disease that occurs when the pulmonary arteries, which are responsible for transporting the blood from the heart to the lungs, become narrowed and obstructed. Due to this defect in the pulmonary arteries, the right heart ventricle needs to work harder to properly pump the blood, making the organ enlarged and weakened. When babies are born with the disease, it is called persistent pulmonary hypertension of the newborn (PPHN), or neonatal pulmonary hypertension. The disease is characterized by a failure in the normal circulatory transition that is inborn in babies and can result in hypoxemia and right-to-left intracardiac shunting of blood. PPHN is not very common, but is a greatly hazardous disease that leads to a high mortality rate.
About Revatio
Revatio was first approved by the European Commission in October 2005 for the treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Revatio is approved for the treatment of pediatric pulmonary arterial hypertension in the EU and Japan.
Since its initial regulatory approval in 2005, Revatio has been approved and launched in more than 50 countries and has amassed more than 650,000 patient-years of experience.
For full Revatio product information for the EU, please see http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000638/human_med_001033.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125.
Indication
Revatio is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs. Revatio improves the ability to exercise and slow down worsening changes in your physical condition.
Limitation of Use: Adding Revatio to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise. Adempas® is a registered trade mark of Bayer HealthCare Pharmaceuticals. Tracleer® is a registered trade mark of Actelion Pharmaceuticals Ltd.
Please see Full Prescribing Information and Patient Information.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
1 Extracorporeal membrane oxygenation, or ECMO, is an advanced life support technique used for patients with life-threatening heart and/or lung problems.
2 In the EU and Japan, Revatio is indicated for the treatment of pediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension
SOURCE: Pfizer
Post Views: 19
NEW YORK, NY, USA I June 28, 2019 I Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the efficacy and safety of intravenous (IV) sildenafil when added to inhaled nitric oxide (iNO) for the treatment of newborns with Persistent Pulmonary Hypertension (PPHN) did not meet its primary efficacy endpoint. Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. Sildenafil is not indicated for the treatment of PPHN. The study was part of an EU Pediatric Investigational Plan (PIP).
About the Study
This Phase 3 study had two consecutive parts: Part A is the randomized, placebo-controlled, double-blind interventional phase to assess efficacy and safety; and Part B is the non-interventional phase with follow-up at 12 and 24 months after the end of study treatment to evaluate developmental progress. These results solely pertain to the outcomes observed from Part A of the study; Part B is ongoing. The co-primary endpoints are treatment failure rate, defined as need for additional PPHN treatment, need for extracorporeal membrane oxygenation1 (ECMO), or death during the study; and time on iNO treatment after initiation of IV study drug for subjects without treatment failure.
The safety and adverse event profile observed in this study was comparable to the known safety profile of Revatio in prior studies in pediatric and adult patients with pulmonary arterial hypertension taking Revatio. Most adverse events were of mild to moderate severity and were consistent with the known pharmacology of phosphodiesterase-5 inhibitors, the class of medications to which Revatio belongs. The benefit-risk profile of Revatio remains favorable for the approved indications when used in accordance with the approved label.
About Pulmonary Hypertension and PPHN
Pulmonary hypertension (PH) is an incurable and life-threatening disease that occurs when the pulmonary arteries, which are responsible for transporting the blood from the heart to the lungs, become narrowed and obstructed. Due to this defect in the pulmonary arteries, the right heart ventricle needs to work harder to properly pump the blood, making the organ enlarged and weakened. When babies are born with the disease, it is called persistent pulmonary hypertension of the newborn (PPHN), or neonatal pulmonary hypertension. The disease is characterized by a failure in the normal circulatory transition that is inborn in babies and can result in hypoxemia and right-to-left intracardiac shunting of blood. PPHN is not very common, but is a greatly hazardous disease that leads to a high mortality rate.
About Revatio
Revatio was first approved by the European Commission in October 2005 for the treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Revatio is approved for the treatment of pediatric pulmonary arterial hypertension in the EU and Japan.
Since its initial regulatory approval in 2005, Revatio has been approved and launched in more than 50 countries and has amassed more than 650,000 patient-years of experience.
For full Revatio product information for the EU, please see http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000638/human_med_001033.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125.
Indication
Revatio is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs. Revatio improves the ability to exercise and slow down worsening changes in your physical condition.
Limitation of Use: Adding Revatio to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise. Adempas® is a registered trade mark of Bayer HealthCare Pharmaceuticals. Tracleer® is a registered trade mark of Actelion Pharmaceuticals Ltd.
Please see Full Prescribing Information and Patient Information.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
1 Extracorporeal membrane oxygenation, or ECMO, is an advanced life support technique used for patients with life-threatening heart and/or lung problems.
2 In the EU and Japan, Revatio is indicated for the treatment of pediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension
SOURCE: Pfizer
Post Views: 19
