* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Sunday, July 27, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    Top 5 entertainment news: Sandeep Reddy Vanga regrets trimming Animal’s runtime by 7-8 minutes, Akshay Ku – Times of India

    Top 5 Entertainment Highlights: Sandeep Reddy Vanga Reveals Why He Trimmed Animal’s Runtime by 7-8 Minutes, Plus Akshay Ku Updates

    Cote de Pablo reveals how Michael Weatherly used his soap opera roots to put her at ease in “NCIS” love scene – yahoo.com

    Cote de Pablo Reveals How Michael Weatherly’s Soap Opera Background Made Their “NCIS” Love Scene Easier

    City of Pelham announces entertainment district plans for former Oak Mountain Amphitheatre site – WVTM

    Pelham Unveils Exciting New Entertainment District Plans for Former Oak Mountain Amphitheatre Site

    Black Box Players presents ‘The Three Musketeers’ – CBS 19 News

    Experience the Adventure: Black Box Players Bring ‘The Three Musketeers’ to Life!

    AP Entertainment SummaryBrief at 1:51 p.m. EDT – Channel 3000

    Entertainment Highlights: Key Updates You Can’t Miss

    ‘Devil Wears Prada 2’ casts Anne Hathaway’s love interest replacing Adrian Grenier’s Nate – Entertainment Weekly

    Devil Wears Prada 2′ Casts New Love Interest for Anne Hathaway, Replacing Adrian Grenier’s Nate

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology

    Eagle Unveils Revolutionary X-Ray Technology at Pack Expo

    Validea’s Top Information Technology Stocks Based On Peter Lynch – 7/25/2025 – Nasdaq

    Validea’s Top Information Technology Stocks Based On Peter Lynch – 7/25/2025 – Nasdaq

    WhoFi: New surveillance technology can track people by how they disrupt Wi-Fi signals – Tech Xplore

    WhoFi: New surveillance technology can track people by how they disrupt Wi-Fi signals – Tech Xplore

    Google Cloud Announced as a Key Technology Partner for Odoo Connect 2025 in San Francisco – GlobeNewswire

    Google Cloud Announced as a Key Technology Partner for Odoo Connect 2025 in San Francisco – GlobeNewswire

    Behind the Screens: The Impact of Technology on Real Estate – TRREB

    Behind the Screens: How Technology is Transforming the Future of Real Estate

    Sustainserv and Palau Announce Technology Partnership to Leverage Innovative AI Platform to Advance Sustainability Reporting – Business Wire

    Sustainserv and Palau Team Up to Transform Sustainability Reporting with Breakthrough AI Technology

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    Top 5 entertainment news: Sandeep Reddy Vanga regrets trimming Animal’s runtime by 7-8 minutes, Akshay Ku – Times of India

    Top 5 Entertainment Highlights: Sandeep Reddy Vanga Reveals Why He Trimmed Animal’s Runtime by 7-8 Minutes, Plus Akshay Ku Updates

    Cote de Pablo reveals how Michael Weatherly used his soap opera roots to put her at ease in “NCIS” love scene – yahoo.com

    Cote de Pablo Reveals How Michael Weatherly’s Soap Opera Background Made Their “NCIS” Love Scene Easier

    City of Pelham announces entertainment district plans for former Oak Mountain Amphitheatre site – WVTM

    Pelham Unveils Exciting New Entertainment District Plans for Former Oak Mountain Amphitheatre Site

    Black Box Players presents ‘The Three Musketeers’ – CBS 19 News

    Experience the Adventure: Black Box Players Bring ‘The Three Musketeers’ to Life!

    AP Entertainment SummaryBrief at 1:51 p.m. EDT – Channel 3000

    Entertainment Highlights: Key Updates You Can’t Miss

    ‘Devil Wears Prada 2’ casts Anne Hathaway’s love interest replacing Adrian Grenier’s Nate – Entertainment Weekly

    Devil Wears Prada 2′ Casts New Love Interest for Anne Hathaway, Replacing Adrian Grenier’s Nate

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology

    Eagle Unveils Revolutionary X-Ray Technology at Pack Expo

    Validea’s Top Information Technology Stocks Based On Peter Lynch – 7/25/2025 – Nasdaq

    Validea’s Top Information Technology Stocks Based On Peter Lynch – 7/25/2025 – Nasdaq

    WhoFi: New surveillance technology can track people by how they disrupt Wi-Fi signals – Tech Xplore

    WhoFi: New surveillance technology can track people by how they disrupt Wi-Fi signals – Tech Xplore

    Google Cloud Announced as a Key Technology Partner for Odoo Connect 2025 in San Francisco – GlobeNewswire

    Google Cloud Announced as a Key Technology Partner for Odoo Connect 2025 in San Francisco – GlobeNewswire

    Behind the Screens: The Impact of Technology on Real Estate – TRREB

    Behind the Screens: How Technology is Transforming the Future of Real Estate

    Sustainserv and Palau Announce Technology Partnership to Leverage Innovative AI Platform to Advance Sustainability Reporting – Business Wire

    Sustainserv and Palau Team Up to Transform Sustainability Reporting with Breakthrough AI Technology

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

EMA Approves Tx for Psoriasis and Other Autoimmune Disorders

February 24, 2024
in Health
EMA Approves Tx for Psoriasis and Other Autoimmune Disorders
Share on FacebookShare on Twitter

In its February 2024 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use has granted marketing authorizations for Pyzchiva (ustekinumab) for the treatment of plaque psoriasis, including pediatric plaque psoriasis; psoriatic arthritis; ulcerative colitis; and Crohn’s disease. It also approved Apremilast Accord (apremilast) for the treatment of psoriatic arthritis, psoriasis, and Behçet disease.

In granting the authorizations, the EMA explained that the biosimilar Pyzchiva was highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in 2009. The EMA added that data showed that Pyzchiva has comparable quality, safety, and efficacy to Stelera.

It also highlighted that Apremilast Accord is a generic of Otezla, which has been authorized in the EU since 2015. Studies had demonstrated the satisfactory quality of Apremilast Accord and its bioequivalence to the reference product Otezla, the EMA said.

Pyzchiva

Ustekinumab is the active substance of Pyzchiva, an immunosuppressant interleukin inhibitor. The monoclonal antibody may exert its clinical effects in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease through interruption of the Th1 and Th17 cytokine pathways, the EMA said in its summary of opinion.

The prevalence of psoriasis is estimated to be 1.92% in Western Europe and 1.83% in Central Europe.

Ustekinumab had been evaluated for the treatment of moderate to severe plaque psoriasis in three phase 3 clinical trials, two placebo-controlled studies (PHOENIX 1 and PHOENIX 2), and one comparator-controlled study (ACCEPT). It was found to be effective in patients who had not received previous treatment, those in whom other immunosuppressive medications had failed, those who were unresponsive to phototherapy, and those who were unable to use or tolerate other therapies.

About 2.5-3 million people in Europe are affected by inflammatory bowel disease, with an estimated prevalence of 0.64 per 100,000 persons in the UK, 1.53 in Portugal, 2.26 in Germany, and 7.1 in France.

The UNITI-1 and UNITI-2 trials demonstrated that ustekinumab was effective and safe when used to treat moderate to severe Crohn’s disease. Among patients with moderately to severely active Crohn’s disease, those receiving intravenous ustekinumab had a significantly higher rate of response than did those receiving placebo. Subcutaneous ustekinumab maintained remission in patients who had a clinical response to induction therapy.

For the treatment of plaque psoriasis and psoriatic arthritis, the drug is usually injected subcutaneously every 4 weeks for the first two doses and then every 12 weeks for as long as treatment continues. For the treatment of Crohn’s disease and ulcerative colitis, it is usually injected intravenously for the first dose and then given subcutaneously every 8 weeks for as long as treatment continues.

Pyzchiva: Full Indications

Moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, or psoralen and ultraviolet A (PUVA).Moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Active psoriatic arthritis — alone or in combination with methotrexate — in adult patients when the response to previous non-biological disease-modifying anti- rheumatic drug (DMARD) therapy has been inadequate.Adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF alpha antagonist or have medical contraindications to such therapies.Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Apremilast Accord 

Apremilast Accord (apremilast) is a phosphodiesterase 4 inhibitor for the treatment of psoriatic arthritis, psoriasis, and Behçet disease. The selective immunosuppressant inhibits the action of phosphodiesterase 4, thereby increasing intracellular cAMP levels, which in turn downregulates the inflammatory response.

The phase 3 ADVANCE trial found that that five times as many adults with mild-to-moderate plaque psoriasis achieved a Static Physician’s Global Assessment (sPGA) response — defined as an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline — at week 16 compared with placebo. In addition, improvements were seen in Whole Body Itch Numeric Rating Scale response and Scalp Physicians Global Assessment.

Behçet disease is uncommon in Europe, with prevalence estimates of 0.64 per 100,000 persons in the UK, 1.2 in Sweden, 1.5 in Portugal, 3.7 in Italy, 5.6 in Spain, and 7.2 in France.

A trial of apremilast for oral ulcers in Behçet disease had found that treatment with the drug resulted in a greater reduction in the number of oral ulcers than placebo.

Taken orally, the dosage is gradually increased until the recommended dose of 30 mg twice daily is reached. The drug is taken continuously to maintain improvement.

Apremilast Accord: Full Indications

Active psoriatic arthritis — alone or in combination with DMARDs — in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.Moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate, or PUVA.Adult patients with oral ulcers associated with Behçet disease who are candidates for systemic therapy.
>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Medscape – https://www.medscape.com/viewarticle/ema-approves-treatments-psoriasis-and-other-autoimmune-2024a10003nw

Tags: ApproveshealthPsoriasis
Previous Post

European Approval for Lung and Skin Cancer Drugs

Next Post

Talking About B-Cell Therapy for Your MS

Clinch County Schools prepare for students’ return with new policies, technology – WALB

Clinch County Schools Prepare for Students’ Return with Exciting New Policies and Cutting-Edge Technology

July 27, 2025
Highlights: Xfinity Series at Indy on The CW – NBC Sports

Unforgettable Thrills Ignite the Xfinity Series at Indy

July 27, 2025
Yellowstone aspen showing signs of recovery following 1995 reintroduction of wolves to park – Oregon State University

Yellowstone Aspen Thriving Again Years After Wolves Were Reintroduced

July 26, 2025
CMC trustees approve new biological science bachelor’s degree – KUNC

CMC Trustees Approve Exciting New Bachelor’s Degree in Biological Sciences

July 26, 2025
By cutting science, the Defense Department is eating its seed corn – Defense News

Cutting Science Funding: How the Defense Department Is Jeopardizing Tomorrow’s Innovation

July 26, 2025
Opinion | Lifestyle Interventions Should Not be Replaced by GLP-1s – MedPage Today

Why Lifestyle Changes Must Stay the Cornerstone-Not GLP-1s

July 26, 2025
World’s most premature baby celebrates first birthday – The Guardian

World’s most premature baby celebrates first birthday – The Guardian

July 26, 2025
Idaho’s first geological engineering degree to power workforce, economy – Bonner County Daily Bee

Idaho Launches Its First Geological Engineering Degree to Boost Workforce and Drive Economic Growth

July 26, 2025
Top 5 entertainment news: Sandeep Reddy Vanga regrets trimming Animal’s runtime by 7-8 minutes, Akshay Ku – Times of India

Top 5 Entertainment Highlights: Sandeep Reddy Vanga Reveals Why He Trimmed Animal’s Runtime by 7-8 Minutes, Plus Akshay Ku Updates

July 26, 2025

How do the microplastics in our bodies affect our health? – BBC

July 26, 2025

Categories

Archives

July 2025
MTWTFSS
 123456
78910111213
14151617181920
21222324252627
28293031 
« Jun    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (740)
  • Economy (764)
  • Entertainment (21,645)
  • General (16,124)
  • Health (9,802)
  • Lifestyle (772)
  • News (22,149)
  • People (766)
  • Politics (773)
  • Science (15,979)
  • Sports (21,262)
  • Technology (15,746)
  • World (747)

Recent News

Clinch County Schools prepare for students’ return with new policies, technology – WALB

Clinch County Schools Prepare for Students’ Return with Exciting New Policies and Cutting-Edge Technology

July 27, 2025
Highlights: Xfinity Series at Indy on The CW – NBC Sports

Unforgettable Thrills Ignite the Xfinity Series at Indy

July 27, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version