BOEHRINGER INGELHEIM


Associated tags: Human, Animal, Boehringer Ingelheim, Animal Health, Pharmaceutical industry, Health, Patient, Research

Locations: SPAIN, DELAWARE, FLORIDA, PENNSYLVANIA, UNITED STATES OF AMERICA, MASSACHUSETTS, ITALY, USA, PHILADELPHIA, EUROPEAN UNION, EU, SWITZERLAND, CANADA, LONDON, GB, TOKYO, INDIA, ENGLAND, MISSOURI, UNITED STATES, NORTH AMERICA, ILLINOIS, CONNECTICUT, INGELHEIM AM RHEIN, DE, III, II, GERMANY, EUROPE, KENYA, FRANCE, BRAZIL, UNITED KINGDOM, JAPAN, GEORGIA

U.S. FDA accepts supplemental New Drug Application for OFEV® (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease

Retrieved on: 
Tuesday, July 25, 2023

"If approved, OFEV would be the first and only approved treatment for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease, representing an important step forward for these patients."

Key Points: 
  • "If approved, OFEV would be the first and only approved treatment for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease, representing an important step forward for these patients."
  • In children and adolescents with fibrosing ILD, a weight-based dosing regimen resulted in exposure of nintedanib similar to adults and with a similar safety profile.
  • The most common adverse event associated with nintedanib compared to placebo in the InPedILD trial was diarrhea.
  • The complete results were published in the European Respiratory Journal (ERJ) and presented at the European Respiratory Society (ERS) International Congress in September 2022.

Boehringer Ingelheim Receives FDA Approval for NexGard® PLUS (afoxolaner, moxidectin and pyrantel chewable tablets): A Beef-Flavored Soft Chew That Protects Dogs from Internal and External Parasites

Retrieved on: 
Thursday, July 20, 2023

By combining internal and external parasite protection in a tasty, beef-flavored soft chew, NexGard® PLUS helps make monthly compliance easy and enjoyable for pets and pet owners.

Key Points: 
  • By combining internal and external parasite protection in a tasty, beef-flavored soft chew, NexGard® PLUS helps make monthly compliance easy and enjoyable for pets and pet owners.
  • Each NexGard® PLUS chew has the same proven afoxolaner dose prescribed to millions of dogs in NexGard® (afoxolaner),6 and an optimized dose of moxidectin that is proven safe and effective.
  • To further enable compliance, veterinarians can prescribe 3-dose and 6-dose presentations to best support the needs of their canine patients.
  • NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) are for use in dogs only.

Spesolimab prevents generalized pustular psoriasis flares in EFFISAYIL™ 2 trial

Retrieved on: 
Tuesday, July 4, 2023

Today, at the 25th World Congress of Dermatology (WCD), Boehringer Ingelheim presented new late-breaking data from the EFFISAYIL™ 2 trial showing that spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo.

Key Points: 
  • Today, at the 25th World Congress of Dermatology (WCD), Boehringer Ingelheim presented new late-breaking data from the EFFISAYIL™ 2 trial showing that spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo.
  • Furthermore, the trial with 123 patients demonstrated no flares after Week 4 of spesolimab treatment in the high dose group.1
    This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20230703881533/en/

Cyltezo®, first and only FDA-approved Interchangeable biosimilar to Humira®, now commercially available in the U.S.

Retrieved on: 
Saturday, July 1, 2023

Cyltezo was approved as an Interchangeable biosimilar in 2021, and is available as a prefilled syringe, or as a Cyltezo® Pen autoinjector.

Key Points: 
  • Cyltezo was approved as an Interchangeable biosimilar in 2021, and is available as a prefilled syringe, or as a Cyltezo® Pen autoinjector.
  • "Cyltezo is the first and only FDA-approved Interchangeable biosimilar to Humira® that is available to the millions of people in the U.S. living with certain chronic inflammatory diseases," said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.
  • An Interchangeable biosimilar must first meet the high FDA standards of a biosimilar.
  • "For many people living with plaque psoriasis or psoriatic arthritis, finding effective relief from symptoms can be a daily struggle.

Boehringer Ingelheim, Fashion Institute of Technology's DTech Lab introduce fifth piece to award-winning design collection that raises awareness of rare disease

Retrieved on: 
Wednesday, June 28, 2023

"Since its introduction last year, The Unwearable Collection has helped to raise much-needed awareness for GPP.

Key Points: 
  • "Since its introduction last year, The Unwearable Collection has helped to raise much-needed awareness for GPP.
  • Trapped by Uncertainty combines unwearable elements, such as shards of glass and crystals, with materials used in everyday fashion design.
  • FIT's Fashion Design team worked under the supervision of Dobriana Gheneva, Assistant Professor, Fashion Design, with creative direction by Michael Ferraro, Executive Director, FIT DTech Lab to create the fifth design.
  • "It was the experiences of people living with GPP and their descriptions of the disease that ultimately inspired me to create The Unwearable Collection.

Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide (BI 456906)

Retrieved on: 
Friday, June 23, 2023

Ingelheim, Germany, and Copenhagen, Denmark, 23 June, 2023 – Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced additional data demonstrating superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment.1 The findings were presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, U.S.

Key Points: 
  • Ingelheim, Germany, and Copenhagen, Denmark, 23 June, 2023 – Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced additional data demonstrating superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment.1 The findings were presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, U.S.
  • “Survodutide may become the first anti-obesity medication to reduce appetite while increasing energy expenditure through the liver.
  • We look forward to furthering our discussions with health authorities to advance this dual receptor agonist into Phase III trials as we aim to help fill a treatment gap in this disease area.”
    “Obesity is one of the most significant healthcare challenges in medicine today,” said David Kendall, M.D., Chief Medical Officer, Zealand Pharma.
  • “At Zealand Pharma, we have both experience and success in discovering and developing peptide therapeutics that target key metabolic pathways – designed to help people living with overweight and obesity by achieving substantial weight loss while addressing the many complications of this disease.”

Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide (BI 456906)1

Retrieved on: 
Friday, June 23, 2023

Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced additional data demonstrating superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment.1 The findings were presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, U.S.

Key Points: 
  • Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced additional data demonstrating superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment.1 The findings were presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, U.S.
  • This press release features multimedia.
  • “Survodutide may become the first anti-obesity medication to reduce appetite while increasing energy expenditure through the liver.
  • “At Zealand Pharma, we have both experience and success in discovering and developing peptide therapeutics that target key metabolic pathways – designed to help people living with overweight and obesity by achieving substantial weight loss while addressing the many complications of this disease.”

Cyltezo®, First Interchangeable Biosimilar to Humira®, Receives Preferred Formulary Status with Optum Rx for Commercially Insured Patients

Retrieved on: 
Friday, June 23, 2023

Cyltezo is an FDA-approved Interchangeable biosimilar to Humira® (adalimumab) and was initially approved in 2017.

Key Points: 
  • Cyltezo is an FDA-approved Interchangeable biosimilar to Humira® (adalimumab) and was initially approved in 2017.
  • "Optum Rx's decision to add Cyltezo to its formulary could benefit millions of Americans, improving access to a crucial medicine that has been a safe and effective treatment for many inflammatory conditions for the last two decades," said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.
  • "We are proud to bring our many decades of experience in complex biologics to the biosimilar space, enabling physicians and patients to feel confident in the science, Interchangeability and manufacturing of Cyltezo."
  • Cyltezo will be commercially available in the U.S. on July 1, 2023.

Jardiance® recommended for the treatment of adults with chronic kidney disease in the EU

Retrieved on: 
Friday, June 23, 2023

“The approval of empagliflozin should greatly help implementation of these important findings into clinical practice for people living with chronic kidney disease,” added Co-Principal Investigator Professor Richard Haynes.

Key Points: 
  • “The approval of empagliflozin should greatly help implementation of these important findings into clinical practice for people living with chronic kidney disease,” added Co-Principal Investigator Professor Richard Haynes.
  • Empagliflozin demonstrated a significant kidney and cardiovascular benefit in adults with CKD, reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent versus placebo.2,3
    “Across the EU, more than 47 million people are living with chronic kidney disease and even more with cardio-renal-metabolic conditions,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim.
  • “We are very excited about the potential for empagliflozin to play a key role in the management of these interconnected cardio-renal-metabolic conditions.”
    “Cardio-renal-metabolic conditions, like chronic kidney disease, type 2 diabetes and heart failure, are a leading cause of death in Europe.
  • We will continue working closely with regulators worldwide so that adults living with chronic kidney disease, and their health care providers, can benefit from empagliflozin as quickly as possible,” continued Leonard Glass, M.D., F.A.C.E., senior vice president, Diabetes & Obesity Global Medical Affairs, Lilly.

American Academy of Dermatology launches innovative project to improve outcomes for patients with life-threatening pustular psoriasis

Retrieved on: 
Thursday, June 22, 2023

The AAD's new Generalized Pustular Psoriasis Education Initiative aims to transform the care of these patients by leveraging the power of data in the Academy's DataDerm™ dermatology patient registry.

Key Points: 
  • The AAD's new Generalized Pustular Psoriasis Education Initiative aims to transform the care of these patients by leveraging the power of data in the Academy's DataDerm™ dermatology patient registry.
  • The project will connect DataDerm's 50 million deidentified patient encounters with OM1's AI-based Patient Finder™ tool to improve understanding of GPP patients' journey, treatment patterns, disease progression, and outcomes.
  • "The American Academy of Dermatology is committed to excellence in dermatology and finding innovative approaches to improve patient care," said AAD President Terrence A. Cronin Jr., MD., FAAD.
  • Findings from the first phase of the project will be shared at the American Academy of Dermatology's 2024 Annual Meeting, March 8 – 12 in San Diego.