HORIZON THERAPEUTICS EARNS FDA APPROVAL FOR TEPEZZA - John G. Baresky
by John G. Baresky on 01/26/20
A first for Thyroid
Eye Disease
Horizon's recently
FDA approved Tepezza is
indicated for the treatment of Thyroid Eye Disease (TED). TED is a healthcare
condition associated with the inflammation of the eyes, eye muscles, eyelids,
tear glands and fatty tissues behind the eye.
Tepezza (teprotumumab-trbw) can be
described as a biologic or biotherapy agent as it is a fully human monoclonal
antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1
receptor (IGF-1R).
Medical issues
associated with TED
TED
is also known as Graves’ Orbitopathy
or Ophthalmopathy and is an autoimmune condition. TED’s symptoms include
outward bulging of the eye which may cause a series of problems such as double
vision, eye pain, light sensitivity or issues with closing the eye. Tepezza may
help some patients prevent more serious challenges with their eyes as a result
of TED including the potential need for surgical procedures. Tepezza is an
injectable product administered via infusion; once every 3 weeks for a total of
8 infusions.
FDA
Director of The Division of Transplant and Ophthalmology Weighs In On Tepezza:
Wiley Chambers, M.D.,
deputy director of the Division of Transplant and Ophthalmology Products in the
FDA’s Center for Drug Evaluation and Research shares these comments about
Tepezza:
“Currently, there are very limited
treatment options for this potentially debilitating disease. This treatment has
the potential to alter the course of the disease, potentially sparing patients
from needing multiple invasive surgeries by providing an alternative, non
surgical treatment option. Additionally, thyroid eye disease is a rare disease
that impacts a small percentage of the population, and for a variety of
reasons, treatments for rare diseases are often unavailable. This approval
represents important progress in the approval of effective treatments for rare
diseases, such as thyroid eye disease.”
FDA requires Horizon
to conduct a post-approval study for Tepezza
As
part of the FDA's approval of Tepezza, Horizon will continue monitoring
Tepezza’s performance in a post marketing study. The study will assess the
product's safety profile in a larger patient population.
About
Horizon Therapeutics
Horizon
Therapeutics (the recently renamed Horizon Pharma) is based in Dublin, Ireland
with a U.S. headquarters located in the Chicago suburb of Lake Forest,
Illinois. Founded in 2005, Horizon's annual revenues are about $1.25 billion.
