Speciality Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Education Dialogues
    • Business Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Speciality Medical Dialogues
    • Editorial
    • News
        • Anesthesiology
        • Cancer
        • Cardiac Sciences
        • Critical Care
        • Dentistry
        • Dermatology
        • Diabetes and Endo
        • Diagnostics
        • ENT
        • Featured Research
        • Gastroenterology
        • Geriatrics
        • Medicine
        • Nephrology
        • Neurosciences
        • Nursing
        • Obs and Gynae
        • Ophthalmology
        • Orthopaedics
        • Paediatrics
        • Parmedics
        • Pharmacy
        • Psychiatry
        • Pulmonology
        • Radiology
        • Surgery
        • Urology
    • Practice Guidelines
        • Anesthesiology Guidelines
        • Cancer Guidelines
        • Cardiac Sciences Guidelines
        • Critical Care Guidelines
        • Dentistry Guidelines
        • Dermatology Guidelines
        • Diabetes and Endo Guidelines
        • Diagnostics Guidelines
        • ENT Guidelines
        • Featured Practice Guidelines
        • Gastroenterology Guidelines
        • Geriatrics Guidelines
        • Medicine Guidelines
        • Nephrology Guidelines
        • Neurosciences Guidelines
        • Obs and Gynae Guidelines
        • Ophthalmology Guidelines
        • Orthopaedics Guidelines
        • Paediatrics Guidelines
        • Psychiatry Guidelines
        • Pulmonology Guidelines
        • Radiology Guidelines
        • Surgery Guidelines
        • Urology Guidelines
    LoginRegister
    Speciality Medical Dialogues
    LoginRegister
    • Home
    • Editorial
    • News
      • Anesthesiology
      • Cancer
      • Cardiac Sciences
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endo
      • Diagnostics
      • ENT
      • Featured Research
      • Gastroenterology
      • Geriatrics
      • Medicine
      • Nephrology
      • Neurosciences
      • Nursing
      • Obs and Gynae
      • Ophthalmology
      • Orthopaedics
      • Paediatrics
      • Parmedics
      • Pharmacy
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
    • Practice Guidelines
      • Anesthesiology Guidelines
      • Cancer Guidelines
      • Cardiac Sciences Guidelines
      • Critical Care Guidelines
      • Dentistry Guidelines
      • Dermatology Guidelines
      • Diabetes and Endo Guidelines
      • Diagnostics Guidelines
      • ENT Guidelines
      • Featured Practice Guidelines
      • Gastroenterology Guidelines
      • Geriatrics Guidelines
      • Medicine Guidelines
      • Nephrology Guidelines
      • Neurosciences Guidelines
      • Obs and Gynae Guidelines
      • Ophthalmology Guidelines
      • Orthopaedics Guidelines
      • Paediatrics Guidelines
      • Psychiatry Guidelines
      • Pulmonology Guidelines
      • Radiology Guidelines
      • Surgery Guidelines
      • Urology Guidelines
    • Home
    • News
    • Anesthesiology
    • FDA grants Fast Track...

    FDA grants Fast Track designation to drug for treatment of Septic Shock

    Written by Deepanjana Sarkar Published On 2019-09-05T19:15:27+05:30  |  Updated On 12 Aug 2021 5:18 PM IST

    The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nangibotide, a TREM-1 (triggering receptor expressed on myeloid cells-1) inhibitor for the treatment of septic shock. TREM-1 inhibitor peptide, which Phase IIb has just been cleared by the FDA, has the potential to restore appropriate inflammatory response, vascular function, and improve post septic shock survival.


    This Fast track designation granted by the Food and Drug Administration is intended to facilitate and expedite development and review of new drugs to address an unmet medical need in the treatment of a serious life-threatening condition and for which nonclinical or clinical data has demonstrated the potential to address this unmet medical need and septic shock is one of them.


    Septic shock is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific therapy approved for this indication besides antibiotics and symptomatic treatment.
    Inotrem's therapeutic solution has the potential to become the first mechanism-based treatment for septic shock.


    "FDA's decision to grant Fast Track designation to nangibotide development program is an important recognition of both Inotrem's innovative therapeutic approach in the management of acute inflammation and the critical need for causal therapies in a severe condition such asseptic shock" said Jean-Jacques Garaud, CEO and co-founder of Inotrem.


    "We look forward to working closely with the Food and Drug Administration, advance our planned ASTONISH trial, and accelerate our efforts to provide the first effective therapy for septic shock patients", added Margarita Salcedo Magguilli, CDO of Inotrem.


    Inotrem recently received an IND clearance by the Food and Drug Administrationfor its ASTONISH trial (Phase IIb). The company will begin its planned global multicentric Phase IIb study in septic shock patients later this year. The Phase IIb study will aim at demonstrating the efficacy of nangibotide and bring clinically relevant proof of clinical activity in septic shock patients. In addition, this study intends to validate a personalized medicine approach using soluble TREM-1 as potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment.

    antibioticsASTONISH trialFast Track DesignationFDAFDA newsinflammatory responseMargarita Salcedo MagguilliMedical newsmedical news indiaNangibotidesepsisseptic shockseptic shock treatmentU.S. Food and Drug Administrationsymptomatic treatmentU.S. Food and Drug Administrationvascular function

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Deepanjana Sarkar
    Deepanjana Sarkar
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 12 Oct 2022 7:06 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok