209360Orig1s000 - Food and Drug Administration

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209360Orig1s000

OTHER REVIEW(S)

DIVISION OF CARDIOVASCULAR AND RENAL PRODUCTS Regulatory Project Manager Overview

I. GENERAL INFORMATION

NDA: 209360 Drug: Giapreza (LJPC-501 ? angiotensin II) Class: Vasoconstrictor Applicant: La Jolla Pharmaceutical Company Proposed Indications: Treatment of hypotension in adults with distributive shock Date of submission: June 29, 2017 PDUFA date: February 28, 2018 Target Action date: December 21, 2017

II. REVIEW TEAM

Office of New Drugs, Office of Drug Evaluation I, Division of Cardiovascular & Renal Product Cross Discipline Team Leader (CDTL): Martin Rose Medical Reviewers: Fortunato Senatore, Tzu-Yun McDowell Pharmacology & Toxicology: Gowra Jagadeesh Regulatory Health Project Manager: Sabry Soukehal

Office of Pharmaceutical Quality Drug Product and environmental assessment (EA): Rao Kambhampati Drug Substance: Raymond Frankewich Microbiology: Jianli Xue Process: Yahong Wang Facility: Jonathan Swoboda Biopharmaceutics: Gerlie Gieser Application Technical Lead: Mohan Sapru

Office of Clinical Pharmacology Venkateswaran ChithambaramPillai

Office of Surveillance and Epidemiology DPV: Amy Chen DMEPA: Sarah Thomas DEPI: Margie Goulding DRISK: Theresa Ng

NDA 209360 RPM Overview Reference ID: 4200118

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Pediatric patients 2 years old:

Draft Protocol Submission: February 2019 Final Protocol Submission: March 2019 Study Completion: September 2023 Final Report Submission: March 2024

All deferred studies (clinical and nonclinical) are post marketing requirements communicated in the action letter.

5. Trade name

On February 8, 2017, the Applicant submitted the proposed proprietary name (b) (4) to IND

122708. This name was denied by the Division of Medication Error Prevention and Analysis

(DMEPA) on August 4, 2017, because it could be confused with the currently marketed product, . (b) (4)

On August 17, 2017, the Applicant submitted the proposed proprietary name

(b) (4) to the

NDA. This name was denied by DMEPA on November 14, 2017 because it could result in

medication errors due to confusion with another product that was also under review by DMEPA.

On November 21, 2017, the Applicant submitted the proposed proprietary name (b) .(4) DMEPA

found it unacceptable based on 21CFR201.10(c)(5) because orthographic similarity to the currently marketed proprietary name, (b) (4)

On December 6, 2017, the Applicant submitted the proposed proprietary name (b) .(4) DMEPA

found it unacceptable based on 21CFR201.10(c)(5) because of similarity in pronunciation to the currently marketed proprietary name, (b) (4)

On December 11, 2017, the Applicant submitted the proposed proprietary name Giapreza for review. This name was considered conditionally acceptable. A grant letter was issued on December 19, 2017

6. Facilities Inspections

The Division of Clinical Compliance Evaluation within the Office of Scientific Investigations did not conduct a facility inspection at the request of the Division of Cardiovascular and Renal Products because the preliminary review of the site-specific database led to the conclusion that there were no outlier sites that would have warranted a site audit. Based on a funnel-plot provided by the statistician, the only site that may have qualified for an audit was the Cleveland Clinic. However, given the highly robust overall results of the study in favor of angiotensin II, exclusion of the data from this site from the primary efficacy analysis could not have materially affected the results.

7. Reviews Below are the conclusions reached by the LJPC-501 team members.

a) Office of Drug Evaluation I decisional memorandum ? December 21, 2017

Dr. Unger performed a benefit-risk assessment and concluded that the demonstrated benefit of LJPC-501 outweighed its potential harms. Dr. Unger concurred with the Division Director and Cross-Disciplinary Team Leader conclusions to approve the NDA and provided additional points not highlighted in the reviews.

NDA 209360 RPM Overview

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Reference ID: 4200118

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