ELAPRASE is a global brand with
over 15 years of real-world experience.
ELAPRASE is available in 77 countries* and has been FDA approved since 2006.1
ELAPRASE is the first and only ERT with 15 years' clinical experience, approved for the treatment of Hunter syndrome in the United States. It is additionally approved in 77* countries worldwide.
ELAPRASE hits 10-year mark. As of July 2016, 1,200 patients, from 134 clinics, in 33 countries had been enrolled in the Hunter Outcome Survey (HOS), making it the largest global source of data on Hunter syndrome.2
10-year anniversary of HOS data and patient enrollment.3
U.S. prescribing information updated to include information about the use of ELAPRASE in children aged 16 months to 5 years of age.1,4
In patients 16 months to 5 years old, ELAPRASE did not show improvement in disease-related symptoms or long term clinical results; however, treatment with ELAPRASE has reduced spleen size similarly to patients 5 years and older.1
It is not known if ELAPRASE is safe and effective in children under 16 months old.1
HOS publication: Evaluated data of idursulfase treatment of Hunter syndrome in children younger than 6 years: results from the HOS.5
ELAPRASE receives FDA approval for use in patients with mucopolysaccharidosis type 2 (MPS II) aged 5 years or older, based on data from the pivotal clinical trial in MPS II patients aged 5–31 years.1,6
HOS began patient enrollment. HOS is a Takeda-sponsored, global, long-term observational survey of MPS II patients established in order to better understand the variability of symptoms and progression of MPS II in the population.5,7
Idursulfase enzyme replacement therapy clinical trial program initiated, beginning with a Phase I/II trial.8
Development of idursulfase, a purified form of the human iduronate-2-sulfatase (I2S) enzyme produced by recombinant DNA technology in a continuous human cell line.7
I2S enzyme amino acid sequence deduced from gene sequence. Discovery of enzyme replacement therapy as a possible treatment for Hunter syndrome.9
Hunter corrective factor found (later known to be I2S, the enzyme deficient or malfunctioning in MPS II patients).10,11
First cases of Hunter syndrome characterized (later also known as MPS II, a member of the MPS family of inherited disorders of glycosaminoglycan (GAG) catabolism).10,12
*Indication and risk information may vary by country.
WARNING: RISK OF ANAPHYLAXIS
Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after ELAPRASE infusions, regardless of duration of the course of treatment. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis.
