* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Monday, June 9, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    Cisco Partners with Monumental Sports & Entertainment to Power New D.C. Arena – Cisco Newsroom

    Cisco Teams Up with Monumental Sports & Entertainment to Revolutionize the New D.C. Arena Experience

    Middle Eastern Entertainment Headlines at 5:49 a.m. GMT – Yahoo

    Exciting Updates from the Middle Eastern Entertainment Scene!

    Ceramic Dalmatian Entertainment is WLAF’s Business of the Week – WLAF

    Spotlight on Success: Ceramic Dalmatian Entertainment Shines as This Week’s Featured Business!

    Brass Lion Entertainment unveils co-op action RPG Wu-Tang: Rise of the Deceiver – VentureBeat

    Unleash Your Inner Warrior: Discover the Co-Op Action RPG Wu-Tang: Rise of the Deceiver!

    Entertainment lineup released for 2025 Mississippi State Fair – WAPT

    Exciting Entertainment Lineup Unveiled for the 2025 Mississippi State Fair!

    After Denzel Washington Said He Would Be In Black Panther 3, Ryan Coogler Explained Why He’s ‘Fine’ With That Information Being Revealed So Early – Yahoo

    Ryan Coogler Shares Why He’s Cool with Denzel Washington’s Black Panther 3 Reveal!

  • 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
    Reeves to Announce £86 Billion for Science and Technology in Spending Review – Bloomberg

    Reeves Set to Unveil Groundbreaking £86 Billion Investment in Science and Technology!

    Innovation at Scale: How P&G Transforms Business Through Technology – Procter & Gamble

    Revolutionizing Business: P&G’s Bold Journey into Technological Innovation

    Drag racer survives frightening airborne crash at World Wide Technology Raceway – FOX 2

    Drag racer survives frightening airborne crash at World Wide Technology Raceway – FOX 2

    Apple Watch and the future of wearable technology in healthcare – MSN

    Revolutionizing Healthcare: The Future of Wearable Technology with Apple Watch

    ECS Professor Pankaj K. Jha Receives NSF Grant to Develop Quantum Technology – Syracuse University News

    Unlocking the Future: ECS Professor Pankaj K. Jha Secures NSF Grant for Groundbreaking Quantum Technology Development

    Fire Tech Brief: 5 Fire Apparatus Technology Upgrades – firehouse.com

    Revving Up Safety: 5 Innovative Upgrades for Fire Apparatus Technology

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    Cisco Partners with Monumental Sports & Entertainment to Power New D.C. Arena – Cisco Newsroom

    Cisco Teams Up with Monumental Sports & Entertainment to Revolutionize the New D.C. Arena Experience

    Middle Eastern Entertainment Headlines at 5:49 a.m. GMT – Yahoo

    Exciting Updates from the Middle Eastern Entertainment Scene!

    Ceramic Dalmatian Entertainment is WLAF’s Business of the Week – WLAF

    Spotlight on Success: Ceramic Dalmatian Entertainment Shines as This Week’s Featured Business!

    Brass Lion Entertainment unveils co-op action RPG Wu-Tang: Rise of the Deceiver – VentureBeat

    Unleash Your Inner Warrior: Discover the Co-Op Action RPG Wu-Tang: Rise of the Deceiver!

    Entertainment lineup released for 2025 Mississippi State Fair – WAPT

    Exciting Entertainment Lineup Unveiled for the 2025 Mississippi State Fair!

    After Denzel Washington Said He Would Be In Black Panther 3, Ryan Coogler Explained Why He’s ‘Fine’ With That Information Being Revealed So Early – Yahoo

    Ryan Coogler Shares Why He’s Cool with Denzel Washington’s Black Panther 3 Reveal!

  • 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
    Reeves to Announce £86 Billion for Science and Technology in Spending Review – Bloomberg

    Reeves Set to Unveil Groundbreaking £86 Billion Investment in Science and Technology!

    Innovation at Scale: How P&G Transforms Business Through Technology – Procter & Gamble

    Revolutionizing Business: P&G’s Bold Journey into Technological Innovation

    Drag racer survives frightening airborne crash at World Wide Technology Raceway – FOX 2

    Drag racer survives frightening airborne crash at World Wide Technology Raceway – FOX 2

    Apple Watch and the future of wearable technology in healthcare – MSN

    Revolutionizing Healthcare: The Future of Wearable Technology with Apple Watch

    ECS Professor Pankaj K. Jha Receives NSF Grant to Develop Quantum Technology – Syracuse University News

    Unlocking the Future: ECS Professor Pankaj K. Jha Secures NSF Grant for Groundbreaking Quantum Technology Development

    Fire Tech Brief: 5 Fire Apparatus Technology Upgrades – firehouse.com

    Revving Up Safety: 5 Innovative Upgrades for Fire Apparatus 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

Emicizumab Safe, Effective, in Infants With Hemophilia A

December 11, 2023
in Health
Emicizumab Safe, Effective, in Infants With Hemophilia A
Share on FacebookShare on Twitter

SAN DIEGO — Administering emicizumab (Hemlibra) to previously untreated or minimally treated infants with severe hemophilia A without factor VIII inhibitors is effective and safe, according to results from research presented here.

The phase III HAVEN-7 study showed that at a median follow-up of 101.9 weeks, the annualized treated bleeding rate was 0.4 (95% CI 0.30-0.63) among 55 study participants, with 30 children (54.5%) having no treated bleeds, reported Steven Pipe, MD, of the University of Michigan in Ann Arbor.

The annualized bleeding rate for all bleeds was 2.0 (95% CI 1.49–2.66), with no treated spontaneous bleeds.

“This was over a median follow up of over 100 weeks, and the median age was 29 months — so these are totally mobilized toddlers through this clinical cut-off date.” Pipe said during a press briefing at the annual meeting of the American Society of Hematology, “Emicizumab prophylaxis really demonstrated consistent efficacy across all the bleeding endpoints.”

For decades the approach to managing hemophilia has been the use of prophylactic factor VIII protein with factor VIII concentrates. Pipe pointed out this is a challenging process because it requires intravenous infusions frequently because of the short half-life of factor VIII.

Emicizumab is a humanized bispecific monoclonal antibody that bridges factor IX and Factor X to substitute for the function of deficient activated factor VIII, and is approved for the routine prophylaxis of persons with hemophilia A.

However, Pipe observed that infants were underrepresented in studies evaluating emicizumab and so HAVEN-7 was initiated in order to provide more evidence for the prophylactic treatment of this population.

Prophylaxis should be the standard of care for infants with hemophilia A, Pipe suggested, but many don’t start receiving prophylaxis until after their first year of life, mostly due to challenges and complications associated with factor VIII administration, such as venous access issues — including situations in which clinicians have had to rely on central venous access devices.

Emicizumab, on the other hand, can be administered subcutaneously from the time of hemophilia A diagnosis, Pipe explained, “This allows us to meet this treatment gap in the first year of life by enabling very early initiation of prophylaxis, and really may mitigate the risk of untreated or spontaneous traumatic bleeding, which can accrue damage, particularly into joints.”

“Importantly, it could mitigate the risk of intracranial hemorrhages,” Pipe added. “There is a substantial risk of intracranial hemorrhage throughout the first year of life for infants who are not yet on prophylactic therapy.”

He also noted that the study offered the opportunity to look at alterations of the natural history of inhibitor development to factor VIII-containing products, “because we would expect infants to have reduced exposure.”

The 55 participants in the study were all male. Median age at enrollment was 4.0 months, with 45.5% under the age of 3 months, and 54.5% between the age of 3 months and 1 year. All received emicizumab for at least 52 weeks, with a median treatment duration of 100.3 weeks.

Prior to the study, 30 (54.5%) infants were minimally treated (≤5 exposure days), and 25 (45.5%) were previously untreated. Participants received subcutaneous emicizumab 3 mg/kg weekly for 4 weeks, then every 2 weeks for 52 weeks. For the study’s 7-year long-term follow-up, participants could continue on this dosing regimen or switch to either 1.5 mg/kg weekly or 6 mg/kg every 4 weeks.

Overall, 207 bleeds (treated or untreated) were reported in 46 participants (83.6%), while 42 treated bleeds, all traumatic, were reported in 25 participants (45.5%). None of the children had>3 treated bleeds, 37 (67.3%) had 0-3 bleeds, and 9 (16.4%) had no bleeds. Two participants had>10 bleeds, all untreated, and none in joint/muscle.

Pipe said no new safety signals were identified, no participants developed anti-drug antibodies directed against emicizumab, and the factor VIII exposure rates were low.

Treatment-related adverse events occurred in 9 patients and all were grade 1 injection site reactions, typically redness or irritation. No adverse events led to withdrawals, dose modifications, or interruptions, “Importantly no intracranial hemorrhages were reported in this cohort,” Pipe said.

Pipe reported that all 55 participants were evaluable for immunogenicity in order to show they had no anti-drug antibodies to emicizumab, and that in about half (28) there was at least one factor VIII exposure. Following factor VIII exposure, 24 participants were evaluated for a factor VIII inhibitor; only two tested positive.

“So this is quite a low rate, but it is related to the really infrequent exposures to factor VIII,” Pipe said. “What’s notable about emicizumab is that its efficacy is not impacted by the appearance of a factor VIII inhibitor, so that patients can continue on prophylaxis with emicizumab, and the two children who tested positive for factor VIII inhibitors have continued on with emicizumab.”

author['full_name']

Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.

Disclosures

HAVEN-7 was sponsored by Hoffmann-La Roche.

Pipe reported relationships with Takeda, Sanofi, Roche/Genentech, Regeneron/Intellia, Pfizer, Novo Nordisk, LFB, Freeline, HEMA Biologics, GenVentiv, Equilibra Bioscience, CSL Behring, BioMarin, Bayer, ASC Therapeutics, ApcinteX, Spark Therapeutics, uniQure.

Primary Source

American Society of Hematology

Source Reference: Pipe S, et al “Emicizumab prophylaxis in infants with severe hemophilia A without factor VIII Inhibitors: results from the primary analysis of the HAVEN 7 study” ASH 2023; Abstract 505.

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MedPageToday – https://www.medpagetoday.com/meetingcoverage/ashhematology/107778

Tags: EffectiveEmicizumabhealth
Previous Post

Add-On Inavolisib Ups PFS in PIK3CA-Mutated Breast Cancer

Next Post

‘New Gold Standard’ for Previously Untreated CLL

PCT Day 16-22 — Ecological Whiplash – The Trek

PCT Day 16-22 — Ecological Whiplash – The Trek

June 9, 2025
Attacks on science are attacks on making and keeping America great: op-ed – AL.com

Attacks on science are attacks on making and keeping America great: op-ed – AL.com

June 9, 2025
Science Confirms: Social Media Could Be Making Kids Depressed – SciTechDaily

Science Confirms: Social Media Could Be Making Kids Depressed – SciTechDaily

June 9, 2025
ZEL Mallorca, the active lifestyle brand of Meliá unveils bold and vibrant signature suite in Mallorca collaboration with Parisian artistic duo, Pangea. – Edomex Al Día

ZEL Mallorca, the active lifestyle brand of Meliá unveils bold and vibrant signature suite in Mallorca collaboration with Parisian artistic duo, Pangea. – Edomex Al Día

June 9, 2025
Power up your play with Nintendo Switch 2 and Mario Kart World launching today – News – Nintendo Official Site – Nintendo

Get Ready to Race: Nintendo Switch 2 and Mario Kart World Launch Today!

June 9, 2025
Lebanon aims to lure back wealthy Gulf tourists to jump-start its war-torn economy – Los Angeles Times

Lebanon Sets Sights on Wealthy Gulf Tourists to Revive Its War-Torn Economy

June 8, 2025
Cisco Partners with Monumental Sports & Entertainment to Power New D.C. Arena – Cisco Newsroom

Cisco Teams Up with Monumental Sports & Entertainment to Revolutionize the New D.C. Arena Experience

June 8, 2025
Couples who cuddle before sleep reap key health benefits, study reveals – Fox News

Couples who cuddle before sleep reap key health benefits, study reveals – Fox News

June 8, 2025
‘Damnit, get somebody in there’: Jimmy Patronis presses Ron DeSantis on CFO vacancy – Florida Politics

Damnit, Get Somebody In There!’ Jimmy Patronis Urges Ron DeSantis to Fill CFO Vacancy Immediately

June 8, 2025
Reeves to Announce £86 Billion for Science and Technology in Spending Review – Bloomberg

Reeves Set to Unveil Groundbreaking £86 Billion Investment in Science and Technology!

June 8, 2025

Categories

Archives

June 2025
MTWTFSS
 1
2345678
9101112131415
16171819202122
23242526272829
30 
« May    
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 (678)
  • Economy (691)
  • Entertainment (21,597)
  • General (15,280)
  • Health (9,733)
  • Lifestyle (695)
  • News (22,149)
  • People (692)
  • Politics (698)
  • Science (15,910)
  • Sports (21,193)
  • Technology (15,677)
  • World (676)

Recent News

PCT Day 16-22 — Ecological Whiplash – The Trek

PCT Day 16-22 — Ecological Whiplash – The Trek

June 9, 2025
Attacks on science are attacks on making and keeping America great: op-ed – AL.com

Attacks on science are attacks on making and keeping America great: op-ed – AL.com

June 9, 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