Shire Plc Bets to Double Sales on Rare Diseases? Drugs Network M?dica, Argentina - Nov 18, 2008 Rare diseases pathologies affect less than 50000 patients a year. Human Genetic Therapies would be a key driver by 2015. By the end of the year HGT sales ...SHPGY
Hudak calls on province to fund ailing boy's treatment St. Catharines Standard, Canada - Nov 21, 2008 Niagara West-Glanbrook MPP Tim Hudak has taken up the fight to fund treatment for a local boy with a rare genetic disorder. On Thursday, Hudak read a ...
UPDATE: Shire Aims To Grow Sales In Mid-Teens Range By 2015 EasyBourse.com, France - Nov 18, 2008 Basingstoke, England-based Shire stepped into the market for rare genetic diseases with the 2005 acquisition of US biotech company Transkaryotic Therapies ...SHPGY
[CITATION] International Approvals: Prexige, Elaprase, Micera Y Waknine
[CITATION] International Approvals: Tysabri, Elaprase, Invega Y Waknine
[CITATION] International Approvals: Nexavar, Elaprase, Aranesp Y Waknine
FDA Approvals: Xolegel, Keppra, and Elaprase CME/CE L Disclaimer - medscape.com ... drug status for idursulfase intravenous infusion (Elaprase, made by Shire Human Genetic Therapies, Inc ... Hunter syndrome is a raregenetic condition caused by ...
[CITATION] FDA Approvals: Xolegel, Keppra, and Elaprase CME/CE T Month, P Months
International Approvals: Mirena, Champix, Elaprase Y Waknine - medscape.com ... 11, the European Commission approved idursulfase intravenous infusion (Elaprase,
made by ... Hunter syndrome is a raregenetic condition caused by an absence or ...
[CITATION] FDA OKs 1st Drug for Hunter Syndrome M Hitti, B Warning
Initial report from the Hunter Outcome Survey. Article JE Wraith, M Beck, R Giugliani, J Clarke, R Martin … - geneticsinmedicine.org ... The development of recombinant human I2S (Elaprase, idursulfase, Shire Human Genetic
Ther- apies ... development of effective treat- ment for rare diseases is ...
AUTHOR AND EDITOR INFORMATION N Braverman - emedicine.com ... Hunter syndrome is rare, but a higher incidence has been noted in the Jewish population ...
It is distributed as Elaprase (Shire Human Genetics Therapies, Inc ... -
Source: Google Scholar
Elaprase Approved for Rare Genetic Disorder
MONDAY, July 24 (HealthDay News) -- Elaprase (idursulfase) was approved Monday by the U.S. Food and Drug Administration as the first drug to treat Hunter syndrome, a rare, inherited disease that can cause premature death.
People with Hunter syndrome, which affects about one of every 65,000 to 132,000 births, cannot break down the body's complex sugars. Symptoms include stunted growth, joint stiffness, and coarse facial features. More severe effects include respiratory, cardiac and neurological problems, enlargement of the liver and spleen, and death, the FDA said in a statement.
Elaprase was approved as an orphan drug, meaning it was developed to treat a condition that affects fewer than 200,000 people. Such approval gives the Massachusetts-based manufacturer, Shire Human Genetic Therapies Inc., seven years of exclusive marketing rights.
Approval was granted following a 96-patient study that found treated patients were able to walk an average of 38 yards more in six minutes than untreated participants, the FDA said.
But some patients did suffer severe hypersensitivity reactions, prompting the agency to advise that "appropriate medical support should be readily available when Elaprase is administered."
