By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
PHARMA JOBS POSTPHARMA JOBS POSTPHARMA JOBS POST
  • HOME
  • FRESHERS
  • LOCATIONS
  • ABOUT US
  • CONTACT
  • DISCLAIMER
Notification
PHARMA JOBS POSTPHARMA JOBS POST
  • HOME
  • FRESHERS
  • LOCATIONS
  • ABOUT US
  • CONTACT
  • DISCLAIMER
Have an existing account? Sign In
Follow US
PHARMA JOBS POST © 2024 All Rights Reserved.
WhatsApp Group Join Now
Telegram Group Join Now
- Advertisement -
Ad imageAd image
Ad imageAd image
PHARMA JOBS POST > FDA approval > FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
FDA approvaltreatment

FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

RAJLAXMI
Last updated: April 16, 2025 1:50 pm
RAJLAXMI 2 months ago 39 Views
Share
SHARE

The U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).

“Today’s approval of Qfitlia is significant for patients with hemophilia because it can be administered less frequently than other existing options,” said Tanya Wroblewski, M.D., deputy director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. “This new treatment option highlights our continued efforts to improve the lives of patients with hemophilia.”

Hemophilia A and hemophilia B are genetic bleeding disorders caused by a dysfunction or deficiency of coagulation factor VIII (FVIII) or IX (FIX), respectively. Patients with these hemophilias are unable to clot properly and may bleed for a longer time than normal after injury or surgery. They may also have spontaneous bleeding in muscles, joints and organs, which can be life-threatening. These bleeding episodes are typically managed by either on-demand, episodic treatment or prophylaxis using products containing FVIII or FIX, or a product that mimics a factor.

Qfitlia does not replace the missing clotting factor. Rather, it reduces the amount of a protein called antithrombin, leading to an increase in thrombin, an enzyme critical for blood clotting.

Qfitlia is administered under the skin (subcutaneously) starting once every two months. The dose and frequency of injections are adjusted using the FDA-cleared INNOVANCE Antithrombin companion diagnostic test. This companion diagnostic is intended to monitor and—by informing dosing and frequency of injections—achieve antithrombin activity in the target range to reduce the risk of bleeding and to reduce the risk of excessive blood clotting. The FDA granted clearance of the INNOVANCE Antithrombin test to Siemens Healthcare Diagnostics GmbH.

Qfitlia’s efficacy and safety were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male patients with either hemophilia A or hemophilia B. In one study, participants had inhibitory antibodies to FVIII or FIX and previously received on-demand treatment with medicines known as “bypassing agents” for bleeding. In the second study, participants did not have inhibitory antibodies to FVIII or FIX and previously received on-demand treatment with clotting factor concentrates. In the two randomized trials, participants received either a fixed dose of Qfitlia monthly or their usual on-demand treatment (bypassing agents or clotting factor concentrates) as needed for nine months. The fixed dose of Qfitlia is not approved because it led to excessive clotting in some patients.

Participants subsequently entered a long-term extension study in which they received an adjustable dose of Qfitlia based on periodic measurements of antithrombin activity. This antithrombin-based dosing regimen is the approved dosage regimen. Efficacy of Qfitlia using the antithrombin-based dosing regimen was established by comparing patients on this dosing regimen of Qfitlia during the long-term extension study to the on-demand control data from the two randomized clinical trials.

WhatsApp Group Join Now
Telegram Group Join Now
- Advertisement -
DEFINE ACADEMY DRUG REGULATORY AFFAIRSDEFINE ACADEMY DRUG REGULATORY AFFAIRS
TAGGED: FDA, Hemophilia A and B
Share This Article
Facebook Twitter LinkedIn Email Print
Previous Article Asipro Hiring for Production Roles – Walk-in Interview on 19 April
Next Article Axis Clinicals Hiring Bioanalytical Professionals | Walk-In Interview 25th April

RECENT POSTS

  • FBL Fermenta Hiring | Walk-In for Production & Plant Operator Roles | 4 June
  • Medical Coding Jobs at Advantmed – Walk-In for Freshers & Experts on 7th & 8th June
  • Join Aspiro: Walk-In Interview for Production Dept on 5 June
  • Marksans Pharma Jobs : Multiple Openings in Softgel Manufacturing
  • Understanding Common Defects in Tablets: A Quality Perspective
  • Walk-In Drive at Harmoni Analytical on 9 June – Hiring Across Departments
  • Sanolet Recruitment Drive – Apply for Production Department Jobs
  • Exciting Job Opportunities at Jambuwala – Apply for Roles in QC, Production, IT & More
  • Join Vital Group – Exciting Job Openings Across Various Departments
  • Acme Generics is Hiring: Quality Assurance Roles Open Now
  • Neuron Pharma Hiring QC Micro Executive – Apply Now
  • Walk-In Drive at Chemveda Life Sciences – Hiring Research Associates in Hyderabad (June 7, 2025)
  • Walk-In Interview at Cadila Pharmaceuticals: Production, QA/QC, Engineering Jobs – 8th June – Pithampur, Madhya Pradesh
JOIN WHATSAPP CHANNEL

Recent Jobs

  • Eugia Pharma Specialities Limited

    Eugia Pharma Offers Career Opportunities Across QA, QC, and Production

    • Dehradun, Uttarakhand
    • Eugia Pharma Specialities Limited
  • Kusum Healthcare Pvt Ltd

    Career Opportunity at Kusum Healthcare Pvt. Ltd. – Join Formulation R&D Team

    • Bhiwadi, Rajasthan
    • Kusum Healthcare Pvt Ltd
  • Avantika Medex Pvt. Ltd.

    Avantika Medex Pvt. Ltd. is Hiring for Regulatory Affairs – Executive IRA

    • Ahmedabad, Gujarat
    • Avantika Medex Pvt. Ltd.
  • Amgen

    Entry-Level Role at Amgen: Associate IS – Signal & Risk Management (Freshers Eligible)

    • India - Hyderabad
    • Amgen
  • Clarivate

    Freshers in Pharmacy/ Life Sciences – Explore Your Future at Clarivate

    • Noida, Uttar Pradesh, India
    • Clarivate
  • Gland Pharma Ltd.

    Gland Pharma’s Mega Hiring Drive for Quality Professionals on 7th June 2025 (Saturday) – Don’t Miss It!

    • Dundigal, Hyderabad
    • Gland Pharma Ltd.
  • Amoli Organics

    24 Job Openings at Amoli Organics – Walk-In at Boisar on 1st June 2025

    • Boisar, Maharashtra
    • Amoli Organics
  • Ayur.AI

    Clinical Research Job for Freshers – Full-Time Role at Ayur.AI

    • Siruseri, Chennai
    • Ayur.AI
  • Mylan Laboratories Limited

    Mylan Laboratories to Conduct Walk-In Interviews for Injectable Manufacturing Roles in Hosur

    • Hosur, Krishnagiri, Tamil Nadu
    • Mylan Laboratories Limited
  • Cadila Pharmaceuticals

    Pharma R&D Jobs: Analyst Vacancy in Analytical Research Laboratory (0–4 Years Exp) at Cadila Pharmaceuticals

    • Dholka, Ahmedabad
    • Cadila Pharmaceuticals
  • Lupin Biotech

    Lupin Biotech to Conduct Walk-in Interviews in Pune for QA, QC, and Biosimilars Roles

    • Pune, Maharashtra
    • Lupin Biotech
  • Ajanta Pharma Ltd.

    Ajanta Pharma Ltd Announces Walk-In Interviews for Multiple Roles at US FDA Approved Facility in Maharashtra

    • Chhatrapati Sambhajinagar
    • Ajanta Pharma Ltd.

Tags

Ahmedabad (65) ahmedabad pharma jobs (189) ahmedabad pharma vacancy (165) ahmedabad pharma walk in interview (89) Baddi Pharma Vacancy (59) Bangalore pharma company jobs (41) Bangalore pharma jobs (31) FRESHERS (181) freshers jobs in pharma industry (50) freshers pharmacy jobs (46) goa pharma company job (27) Hiring (119) Hiring jobs (463) Hyderabad (57) hyderabad pharma company jobs (184) hyderabad pharma jobs (94) hyderabad pharma jobs freshers (42) hyderabad pharma vacancies (111) hyd pharma jobs (31) indore pharma company vacancy (27) job alert (384) job Opportunity (246) Job search (462) job Vaccancy (452) Mumbai Pharma company jobs (34) Pharmacovigilance Jobs vacancy (38) Pharma jobs (104) Pharma jobs at Baddi (36) pharma jobs in hyderabad (84) Pharma QA Jobs (35) pharma qa vacancy (28) pharma vacancy in ahmedabad (30) pharma walk in interview (44) Production (58) Production Department (73) QA (53) QC (77) QC Department (45) Quality Control (QC) (32) Regulatory Affairs (55) Regulatory Affairs Jobs Vacancy (63) Vadodara (33) Vadodara Pharma Job Vacancy (53) Walk In Drive (125) Walk In Interview (180)
PHARMA JOBS POSTPHARMA JOBS POST
Follow US
PHARMA JOBS POST © 2024 All Rights Reserved.
JOIN OUR WHATSAPP GROUP
JOIN OUR TELEGRAM GROUP
Welcome Back!

Sign in to your account

Lost your password?