X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

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

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

  • 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

Novartis sickle cell medicine Adakveo approved in Europe to prevent recurrent vaso-occlusive crises

Content Team by Content Team
5th November 2020
in FDA Approvals, News
Novartis sickle cell medicine Adakveo approved in Europe to prevent recurrent vaso-occlusive crises

Novartis announced that the European Commission (EC) has approved Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises (VOCs), or pain crises, in patients with sickle cell disease aged 16 years and older.1 Adakveo can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.

Adakveo binds to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion.2,3 Sickle cell disease is considered a rare blood condition, affecting about 50,000 people in Europe.4,5

“Data shows that nine out of ten people living with sickle cell disease experience one or more VOCs in a year, with a third of those crises leading to hospitalization, underscoring the significant unmet need among a vulnerable group of patients,” said Kees Roks, Head Region Europe, Novartis Oncology. “Just one VOC could be catastrophic for the patient, so preventing these sudden, unpredictable and life-threatening events is hugely important. Today’s decision gives people living with sickle cell disease a chance to achieve that goal.”

The approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July based on results of the SUSTAIN trial, which showed that Adakveo significantly lowered the median annual rate of VOCs to 1.63 vs 2.98 compared with placebo (P=.010), equivalent to a 45% reduction. There was also a greater than two-fold increase in the proportion of patients with no VOCs who completed the study, compared to placebo. Reductions in the frequency of VOCs were observed among patients regardless of sickle cell disease genotype and/or hydroxyurea/hydroxycarbamide (HU/HC) use. In the same study, Adakveo was shown to reduce the median annual rate of days hospitalized by 42% (4.0 days for Adakveo vs. 6.87 days for placebo).6 Read more about the positive CHMP opinion and the SUSTAIN clinical trial results here.

About Adakveo

Adakveo (crizanlizumab) – previously known as SEG101 – is indicated for the prevention of recurrent VOCs in patients with sickle cell aged 16 years and older. It can be given as an add-on therapy to HU/HC or as monotherapy in patients for whom HU/HC is inappropriate or inadequate. It is the first and only targeted biologic that works by binding to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion in sickle cell disease. By binding to P-selectin on the surface of the activated endothelium and platelets, Adakveo blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes.

Previous Post

Novartis announces collaboration with Molecular Partners to develop two DARPin therapies designed for potential use against COVID-19

Next Post

Lilly and Incyte Highlight Positive Data for Olumiant in Rheumatoid Arthritis

Related Posts

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Pharma Drugs Gain From Tardigrade Proteins, Says Research
Drug Development

Pharma Drugs Gain From Tardigrade Proteins, Says Research

22nd March 2023
Next Post
Lilly to invest $400m to boost manufacturing capacity in US

Lilly and Incyte Highlight Positive Data for Olumiant in Rheumatoid Arthritis

Latest News

Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Drug Development

AADC Inadequacy To Be Handled By A Novel Gene Therapy

24th March 2023
Drug Development

New Drug Explored For Epilepsy Gets $3M Funding In Australia

23rd March 2023
Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
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