Home Regulatory IQVIA selected to accelerate clinical development of VYVGART by argenx SE

IQVIA selected to accelerate clinical development of VYVGART by argenx SE

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IQVIA

Synopsis :

IQVIA announced an agreement today with argenx SE. The multi-year contract covers a unique collaboration for the development of new indications for VYVGART™ (efgartigimod alfa fcab), an FDA-approved neonatal Fc receptor blocker for the treatment of generalized myasthenia gravis in adult patients who have a specific antibody receptor.

While terms of the deal have not been disclosed, the collaboration will support clinical development, regulatory, commercial and real-world evidence strategy to accelerate the development of new indications for VYVGART.

“We are excited to be working with argenx in a comprehensive way to support the development of their promising new treatment,” said Alistair Grenfell, president, Europe, Middle East, Africa and South Asia for IQVIA. “IQVIA’s end-to-end support will speed the clinical development and the commercial launch of new indications that drive argenx’s success. Together, our partnership will create new opportunities to improve human health and bring new hope to patients and their families.”

IQVIA

IQVIA

IQVIA brings together deep scientific expertise with unique technology and analytics to enable life sciences companies such as argenx to accelerate the clinical development and commercialization of innovative products that improve patient lives.

About VYVGART™

Efgartigimod alfa, sold under the brand name Vyvgart, is a medication used to treat myasthenia gravis. The most common side effects include respiratory tract infections, headache, and urinary tract infections. Efgartigimod alfa is a neonatal Fc receptor blocker and is a new class of medication

Important Safety Information

What is VYVGARTTM (efgartigimod alfa-fcab)?

VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

What is the most important information I should know about VYVGART?   

VYVGART may cause serious side effects, including:

  • Infection. VYVGART may increase the risk of infection. In a clinical study, the most common infections were urinary tract and respiratory tract infections. More patients on VYVGART vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and blood side effects were mild to moderate in severity. Your health care provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART. Tell your health care provider if you have any history of infections. Tell your health care provider right away if you have signs or symptoms of an infection during treatment with VYVGART such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
  • Undesirable immune reactions (hypersensitivity reactions). VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART discontinuation. Your health care provider should monitor you during and after treatment and discontinue VYVGART if needed. Tell your health care provider immediately about any undesirable reactions.

About Phase 3 ADAPT Trial 

The Phase 3 ADAPT trial was a 26-week randomized, double-blind, placebo-controlled, multi-center, global trial evaluating the safety and efficacy of VYVGART in adult patients with gMG. A total of 167 adult patients with gMG in North America, Europe and Japan enrolled in the trial. Patients were randomized in a 1:1 ratio to receive VYVGART or placebo, in addition to stable doses of their current gMG treatment. ADAPT was designed to enable an individualized treatment approach with an initial treatment cycle followed by subsequent treatment cycles based on clinical evaluation. The primary endpoint was the comparison of percentage of MG-ADL responders in the first treatment cycle between VYVGART and placebo treatment groups in the anti-AChR antibody positive population.

About Generalized Myasthenia Gravis

Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months1, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population1.

About IQVIA

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 79,000 employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors, and scientific advances, in an effort to advance their path toward cures.

To learn more, visit www.iqvia.com.

References

1 Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277

2Howard JF Jr, Utsugisawa K, Benatar M, et al. Safety and efficacy of efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicenter study. Lancet Neurol. 2017; 16: 976-86

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