Submission Based on Phase 3 Program Conducted Under Special Protocol Assessment and 12-Month Phase 2 Safety, Efficacy and Tolerability Data
REDWOOD CITY, CA, USA I October 22, 2014 I Relypsa, Inc. (RLYP), today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood.
The NDA is supported by eight clinical trials, including a Phase 3 program that was conducted under a Special Protocol Assessment as well as a Phase 2 trial that evaluated Patiromer FOS in patients for up to one year.
“Our submission of the NDA for Patiromer FOS is an important milestone, which sets the stage for NDA acceptance and regulatory review of our application and ultimately, potential approval of the drug and potentially marking the first new therapeutic innovation available to treat patients with hyperkalemia in over 50 years,” said John A. Orwin, president and chief executive officer of Relypsa. “We look forward to offering patients a potential treatment for hyperkalemia that can normalize their potassium levels in acute and chronic settings. Based on the efficacy and safety of twice daily dosing demonstrated in clinical studies, as well as the early onset of action and favorable safety profile for up to one year, we believe that Patiromer FOS has the potential to become a preferred treatment option for hyperkalemia.”
Lance Berman, chief medical officer of Relypsa added, “We believe that the clinical development program for Patiromer FOS is the first to provide robust clinical data for the evaluation of efficacy of a therapy for the treatment of hyperkalemia. To our knowledge, Patiromer FOS is the first therapy to date that has successfully completed a prospective 12-month evaluation of safety, efficacy and tolerability in a long term, chronic treatment setting in hyperkalemic patients.”
About Hyperkalemia and Patiromer
Hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood, is frequently prevalent in patients who suffer from chronic kidney disease, hypertension, diabetes and/or heart failure. Hyperkalemia can lead to life-threatening cardiac arrhythmia and sudden death. Patients with chronic kidney disease or heart failure are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors such as ARBs (Angiotensin Receptor Blockers), AAs (Aldosterone Antagonists), and ACE (Angiotensin-Converting-Enzyme) inhibitors. Although RAAS inhibition has been shown to protect kidney and cardiac function, many patients who could benefit from RAAS inhibitors are untreated or undertreated due to the undesirable side effect of increasing serum potassium.
Patiromer for Oral Suspension is a high capacity, oral potassium binder being developed for the treatment of hyperkalemia. The compound has been evaluated in CKD patients with hyperkalemia, including a two part Phase 3 program, a 12-month Phase 2 trial and a 48-hour Phase 1 onset-of-action trial. In all of those trials , Patiromer FOS met its efficacy endpoints and the treatment was well tolerated. The pivotal clinical trial for Patiromer FOS was conducted under a Special Protocol Assessment with the FDA.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. The company’s two-part pivotal Phase 3 trial of its lead product candidate, Patiromer for Oral Suspension, for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood, has been completed and the primary and secondary endpoints were met. Relypsa has global royalty-free commercialization rights to Patiromer for Oral Suspension, which has intellectual property protection in the U.S. until at least 2030. More information is available at www.relypsa.com.
SOURCE: Relypsa
Post Views: 118
Submission Based on Phase 3 Program Conducted Under Special Protocol Assessment and 12-Month Phase 2 Safety, Efficacy and Tolerability Data
REDWOOD CITY, CA, USA I October 22, 2014 I Relypsa, Inc. (RLYP), today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood.
The NDA is supported by eight clinical trials, including a Phase 3 program that was conducted under a Special Protocol Assessment as well as a Phase 2 trial that evaluated Patiromer FOS in patients for up to one year.
“Our submission of the NDA for Patiromer FOS is an important milestone, which sets the stage for NDA acceptance and regulatory review of our application and ultimately, potential approval of the drug and potentially marking the first new therapeutic innovation available to treat patients with hyperkalemia in over 50 years,” said John A. Orwin, president and chief executive officer of Relypsa. “We look forward to offering patients a potential treatment for hyperkalemia that can normalize their potassium levels in acute and chronic settings. Based on the efficacy and safety of twice daily dosing demonstrated in clinical studies, as well as the early onset of action and favorable safety profile for up to one year, we believe that Patiromer FOS has the potential to become a preferred treatment option for hyperkalemia.”
Lance Berman, chief medical officer of Relypsa added, “We believe that the clinical development program for Patiromer FOS is the first to provide robust clinical data for the evaluation of efficacy of a therapy for the treatment of hyperkalemia. To our knowledge, Patiromer FOS is the first therapy to date that has successfully completed a prospective 12-month evaluation of safety, efficacy and tolerability in a long term, chronic treatment setting in hyperkalemic patients.”
About Hyperkalemia and Patiromer
Hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood, is frequently prevalent in patients who suffer from chronic kidney disease, hypertension, diabetes and/or heart failure. Hyperkalemia can lead to life-threatening cardiac arrhythmia and sudden death. Patients with chronic kidney disease or heart failure are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors such as ARBs (Angiotensin Receptor Blockers), AAs (Aldosterone Antagonists), and ACE (Angiotensin-Converting-Enzyme) inhibitors. Although RAAS inhibition has been shown to protect kidney and cardiac function, many patients who could benefit from RAAS inhibitors are untreated or undertreated due to the undesirable side effect of increasing serum potassium.
Patiromer for Oral Suspension is a high capacity, oral potassium binder being developed for the treatment of hyperkalemia. The compound has been evaluated in CKD patients with hyperkalemia, including a two part Phase 3 program, a 12-month Phase 2 trial and a 48-hour Phase 1 onset-of-action trial. In all of those trials , Patiromer FOS met its efficacy endpoints and the treatment was well tolerated. The pivotal clinical trial for Patiromer FOS was conducted under a Special Protocol Assessment with the FDA.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. The company’s two-part pivotal Phase 3 trial of its lead product candidate, Patiromer for Oral Suspension, for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood, has been completed and the primary and secondary endpoints were met. Relypsa has global royalty-free commercialization rights to Patiromer for Oral Suspension, which has intellectual property protection in the U.S. until at least 2030. More information is available at www.relypsa.com.
SOURCE: Relypsa
Post Views: 118
