X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development FDA Approvals

Jazz Pharmaceuticals Announces FDA Acceptance for Filing with Priority Review of NDA for Defibrotide

Yuvraj_pawp by Yuvraj_pawp
24th October 2015
in FDA Approvals

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for defibrotide. Defibrotide is an investigational agent proposed for the treatment of patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).

Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. Based on timelines established by the Prescription Drug User Fee Act (PDUFA), FDA review of the NDA is expected to be completed by March 31, 2016.

“The FDA’s acceptance for filing and Priority Review status of the NDA for defibrotide is an important milestone for Jazz and reflects our commitment to bringing meaningful medicines to patients who have significant unmet needs,” said Karen Smith, M.D., Ph.D., Global Head of Research and Development and Chief Medical Officer of Jazz Pharmaceuticals. “We look forward to continuing to work closely with the FDA to obtain approval for defibrotide for patients with hepatic VOD with evidence of MOD in the U.S. as quickly as possible, as there are no other approved therapies for treating this rare, often fatal complication of HSCT.”

The NDA includes safety and efficacy data from three clinical studies of defibrotide for the treatment of hepatic VOD with MOD following HSCT, as well as a retrospective review of registry data from the Center for International Blood and Marrow Transplant Research. The safety database includes over 900 patients exposed to defibrotide in the clinical development program for the treatment of hepatic VOD.

“We applaud the FDA for working with Jazz in accepting this application for a timely review as bone marrow transplant patients who develop VOD with MOD currently have no effective options for this potentially life-threatening syndrome,” said Susan K. Stewart, Executive Director, BMT InfoNet (Blood & Marrow Transplant Information Network).

Tags: America
Previous Post

Collegium Provides Update on FDA Review of Xtampza ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain

Next Post

Ulcerative Colitis Presented at ACG Plenary Session

Related Posts

New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System
FDA Approvals

New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

31st January 2022
Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19
FDA Approvals

Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

29th January 2022
Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations
FDA Approvals

Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

29th January 2022
EC Approves Merck's KEYTRUDA as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma Following Surgery
FDA Approvals

EC Approves Merck’s KEYTRUDA as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma Following Surgery

29th January 2022
Cystic Fibrosis Treatment Approved By European Commission
FDA Approvals

Cystic Fibrosis Treatment Approved By European Commission

17th January 2022
Catalent and Zumutor Biologics Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors
FDA Approvals

New lung cancer treatment combo approved on NHS in England

17th January 2022
Next Post

Ulcerative Colitis Presented at ACG Plenary Session

Latest News

Envirotainer introduces the RAP for the future - part of the Releye series
Packaging & Logistic

Envirotainer introduces the RAP for the future – part of the Releye series

14th February 2022
United Cargo Meets Growing Demand for Pharmaceuticals with New TempControl Containers
Packaging & Logistic

Opticooler receives technical approval by Japanese major airlines

14th February 2022
Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease
Press Statements

Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease

14th February 2022
Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
News

Indian Scientists Claim To Design Vaccine For All Variants

9th February 2022
Drones for Delivery To Carry Pharmaceutical Weight Forward
News

Drones for Delivery To Carry Pharmaceutical Weight Forward

9th February 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In