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NDA/BLA Multidisciplinary Review and Evaluation NDA 212832 Potassium Phosphates Injection, USP

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NDA/BLA Multidisciplinary Review and Evaluation NDA 212832 Potassium Phosphates Injection, USP NDA/BLA Multidisciplinary Review and Evaluation NDA 212832 Potassium Phosphates Injection, USP NDA/BLA Multidisciplinary Review and Evaluation Application type NDA Application number(s) 212832 Priority or standard Priority Submit date(s) 5/29/19 Received date(s) 5/29/19 PDUFA goal date 11/29/19 Division/office Division of Gastroenterology and Inborn Errors Products (DGIEP) Review completion date November 26, 2019 Established/proper name Potassium Phosphates Injection, USP (Proposed) trade name None Pharmacologic class Parenteral Phosphorus Replacement Applicant Fresenius Kabi USA, LLC Dosage form Injection • Phosphorus 15 mmol/5 mL (3 mmol/mL) and potassium 22 mEq/5 mL (4.4 mEq/mL) in a single-dose vial. • Phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in a single-dose vial. • Phosphorus 150 mmol/50 mL (3 mmol/mL) and potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package vial. (b) (4) Applicant-proposed dosing regimen For Use in Parenteral Nutrition In patients on total parenteral nutrition, approximately 12 to 15 millimoles of phosphorus (equivalent to 372 to 465 mg elemental phosphorus) per liter bottle of total parenteral nutrition (TPN) solution containing 250 g dextrose is usually adequate to maintain normal serum phosphorus, though larger amounts may be required in hypermetabolic states. The amount of potassium and phosphorus which accompanies the addition of potassium phosphate also should be kept in mind, and if necessary, serum potassium levels should be monitored. Applicant-proposed Potassium Phosphates Injection, USP is indicated as a source of indication(s)/population(s) phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. i Version date: October 12, 2018 Reference ID: 4525949 NDA/BLA Multidisciplinary Review and Evaluation NDA 212832 Potassium Phosphates Injection, USP Recommendation on Approval as a source of phosphorus for correction of hypophosphatemia regulatory action in intravenous fluids and in parenteral nutrition Recommended Potassium Phosphates Injection, USP is indicated as a source of indication(s)/population(s) phosphorus: (if applicable) • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated Recommended dosing Dosing for both indications can be found in Section 11, Labeling regimen ii Version date: October 12, 2018 Reference ID: 4525949 NDA/BLA Multidisciplinary Review and Evaluation NDA 212832 Potassium Phosphates Injection, USP Table of Contents Table of Tables .................................................................................................................... vi Reviewers of Multidisciplinary Review and Evaluation ..................................................... vii Glossary ............................................................................................................................... ix 1. Executive Summary ......................................................................................................... 1 1.1. Product Introduction ................................................................................................ 1 1.2. Conclusions on Substantial Evidence of Effectiveness ............................................. 3 1.3. Benefit-Risk Assessment .......................................................................................... 5 1.4. Patient Experience Data ......................................................................................... 11 2. Therapeutic Context ..................................................................................................... 12 2.1. Analysis of Condition .............................................................................................. 12 2.1.1. Phosphorus ...................................................................................................... 12 2.1.2. Hypophosphatemia ......................................................................................... 13 2.1.3. Phosphorus Use in Parenteral Nutrition ......................................................... 18 2.2. Analysis of Current Treatment Options ................................................................. 19 3. Regulatory Background ................................................................................................. 21 3.1. U.S. Regulatory Actions and Marketing History ..................................................... 21 3.2. Summary of Presubmission/Submission Regulatory Activity ................................ 21 3.2.1. IND 130166 ...................................................................................................... 21 4. Significant Issues From Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety ............................................................................. 23 4.1. Office of Scientific Investigations ........................................................................... 23 4.2. Product Quality....................................................................................................... 23 4.2.1. Drug Substances .............................................................................................. 23 4.2.2. Drug Product .................................................................................................... 23 4.3. Clinical Microbiology .............................................................................................. 25 5. Nonclinical Pharmacology/Toxicology .......................................................................... 26 5.1. Executive Summary ................................................................................................ 26 5.2. Referenced NDAs, BLAs, DMFs ............................................................................... 26 5.3. Toxicology ............................................................................................................... 26 5.3.1. Safety Assessment of Elemental Impurities .................................................... 26 5.3.2. Safety Assessment of Aluminum ..................................................................... 27 5.3.3. Safety Assessment of Extractables/Leachables ............................................... 28 6. Clinical Pharmacology ................................................................................................... 29 6.1. Executive Summary ................................................................................................ 29 iii Version date: October 12, 2018 Reference ID: 4525949 NDA/BLA Multidisciplinary Review and Evaluation NDA 212832 Potassium Phosphates Injection, USP 6.1.1. Recommendations ........................................................................................... 29 6.2. Summary of Clinical Pharmacology Assessment .................................................... 30 6.2.1. General Dosing and Therapeutic Individualization ......................................... 30 6.2.1. Pharmacology and Clinical Pharmacokinetics ................................................. 31 6.3. Comprehensive Clinical Pharmacology Review ..................................................... 32 6.3.1. General Pharmacology and Pharmacokinetic Characteristics ......................... 32 6.3.2. Clinical Pharmacology Questions .................................................................... 33 6.3.2.1. Does the clinical pharmacology program provide supportive evidence of effectiveness? ..................................................................................................... 33 6.3.2.2. Is the proposed dosing regimen appropriate for the general patient population for which the indication is being sought? ........................................ 33 6.3.2.3. Is an alternative dosing regimen or management strategy required for subpopulations based on intrinsic patient factors? ........................................... 36 6.3.2.4. Are there clinically relevant food-drug or drug-drug interactions, and what is the appropriate management strategy? ................................................ 37 7. Sources of Clinical Data and Review Strategy ............................................................... 38 7.1. Table of Clinical Studies .......................................................................................... 38 7.2. Review Strategy ...................................................................................................... 46 8. Clinical Evaluation ......................................................................................................... 47 8.1. Review of Evidence Used to Support Efficacy ........................................................ 47 8.1.1. Correction of Hypophosphatemia in Intravenous Fluids ................................ 47 8.1.1.1. Listed drug (LD) ..................................................................................................... 47 8.1.1.2. Relevant published clinical trials ........................................................................... 47 8.1.2. Use in Parenteral Nutrition
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