WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced that the US Food and Drug Administration’s
(FDA) Arthritis Advisory Committee (AAC) voted 10-4 to recommend the
approval of lesinurad 200 mg tablets for the treatment of hyperuricemia
associated with gout, in combination with a xanthine oxidase inhibitor
(XOI). About Depakote (Divalproex) without prescription The AAC reviewed safety and efficacy data from the pivotal Phase
III combination therapy program trials, representing the largest
clinical trial data set of gout patients treated with combination urate
lowering therapy.
The FDA is not bound by the Advisory Committee’s recommendation but
takes its advice into consideration when reviewing the application for a
potential medicine. About Rogaine (Minoxidil) with no Rx The Prescription Drug User Fee Act (PDUFA) target
goal date for lesinurad is December 29, 2015.
If approved, lesinurad will be the first selective uric acid
reabsorption inhibitor, or SURI, in the US. About Astelin (Azelastine) without Rx It inhibits the urate
transporter, URAT1, which is responsible for the majority of the renal
reabsorption of uric acid.
Sean Bohen, Executive Vice President of Global Medicines Development and
Chief Medical Officer, AstraZeneca, said: “The Committee’s positive
recommendation for lesinurad is an encouraging step for patients
suffering from the debilitating effects of gout, a disease in which
there has been limited treatment innovation over the last 50 years. About Griseofulvin with free prescription We
look forward to the outcome of the FDA’s review and the opportunity to
provide a new treatment option that when combined with an XOI addresses
both the under-excretion and over-production of uric acid, the
underlying causes of gout.”
Gout is a serious and debilitating form of inflammatory arthritis caused
by hyperuricemia (elevated serum uric acid (sUA)). Buy Dilantin (Phenytoin) with free prescription Gout affects millions
of Americans, many of whom do not reach recommended sUA treatment goals
on the current standard of care (XOIs), which decrease production of
uric acid. Buy Food Based Calcium and Magnesium online For those inadequately controlled patients, the addition of a
urate lowering therapy to increase excretion of uric acid, may help them
achieve treatment goals.
Lesinurad is also under regulatory review in the European Union and
other territories.
NOTES TO EDITORS
About Lesinurad
If approved, lesinurad will be the first selective uric acid
reabsorption inhibitor, or SURI, in the US. http://webmd-help.blogspot.com It inhibits the urate
transporter, URAT1, which is responsible for the majority of the renal
reabsorption of uric acid. By inhibiting URAT1, lesinurad increases uric
acid excretion and thereby lowers serum uric acid (sUA). Lesinurad also
inhibits organic anion transporter (OAT4) a uric acid transporter
involved in diuretic-induced hyperuricemia. In addition, in patients,
lesinurad does not inhibit OAT1 and OAT3, which are drug transporters in
the kidney associated with drug-drug interactions.
If approved, lesinurad in combination with an XOI would provide a dual
mechanism of action to increase excretion and decrease production of
uric acid enabling more patients with inadequately controlled gout to
achieve target treatment goals.
About Hyperuricemia and Gout
Gout is a serious, chronic, progressive, and debilitating form of
inflammatory arthritis. Currently, there are more than 8.3 million
patients suffering from gout in the US. The underlying cause of gout is
hyperuricemia (elevated serum uric acid (sUA)), which leads to the
deposition of crystals primarily in the joints and in other tissues.
This can result in recurrent attacks of inflammatory arthritis and, if
left uncontrolled, could lead to chronic, progressive arthritis, and
tophus (visible deposits of urate crystals) formation.
The goal of sUA lowering treatment is to reduce sUA levels tothe target
level of <6.0 mg/dL as recommended by the American College of
Rheumatology (ACR). To improve signs and symptoms such as tophaceous
gout, the ACR guidelines state that achieving and maintaining sUA levels
<5.0 mg/dL may be required.
Among patients treated in clinical trials, less than 50% of patients on
allopurinol 300 mg reached serum uric acid (sUA) target levels <6.0
mg/dL. This suggests approximately two million gout patients in the US
on urate lowering therapy remain inadequately controlled. For patients
who cannot reach target on an XOI alone, the current ACR guidelines
recommend adding an agent that increases uric acid excretion.
About Ardea Biosciences
Ardea Biosciences, Inc. was acquired by AstraZeneca in June 2012. It is
located in San Diego, California and is a member of the AstraZeneca
Group. Ardea is leading the development of AstraZeneca’s gout portfolio,
including lesinurad and RDEA3170. RDEA3170 is a potent selective uric
acid reabsorption inhibitor (SURI), also intended for use as a
combination urate lowering therapy with xanthine oxidase inhibitors
(XOIs). RDEA3170 is our lead investigational urate lowering therapy
(ULT) in Asia and is currently entering a Phase IIb trial in the US.
About AstraZeneca
AstraZeneca (NYSE: AZN) is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialization of prescription medicines, primarily for the treatment
of cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates in
over 100 countries and its innovative medicines are used by millions of
patients worldwide. For more information please visit: .astrazeneca-us.com.
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24 October 2015
10 October 2015
ELLENTON, Fl orida--(BUSINESS WIRE)--A fam ilia Feld, propriet aria da Feld Entertainment, Inc. Buy Cellcept (Mycophenolate Mofetil) with no Rx – empresa
matriz do Ringling Bros. About Temovate (Clobetasol) without Rx and Barnum & Bailey®
e do Ringling Bros. About Exelon (Rivastigmine Tartrate) Center for Elephant Conservation®
–, anunciou ontem um novo esforco de financiamento com o Intermountain
Primary Children’s Hospital (PCH), com oncologistas do Departamento de
Pediatria da Universidade de Utah e com o Dr. Genpril with free Rx Joshua Schiffman do
Huntsman Cancer Institute. Buy Evecare () without prescription O compromisso de captac~ao de recursos vem na
sequ^encia de novas descobertas de uma pesquisa sobre c^ancer publicada
pelo Dr. Buy Erectile Dysfunction online Schiffman no Journal of American Medical Association (JAMA), o
peri odico cient ifico da Associac~ao M edica Americana.
A Feld Entertainment lancou hoje um pacote de v ideo de acompanhamento
que descreve a pesquisa. http://webmd-review.blogspot.com O v ideo pode ser visto aqui.
Dr. Schiffman e a equipe do Primary Children’s Hospital, do Departamento
de Pediatria e do Huntsman Cancer Institute – todos situados em Salt
Lake City, Utah – est~ao estudando por que h a uma incid^encia t~ao baixa de
c^ancer em elefantes, o que torna poss ivel essa resist^encia `a doenca
entre elefantes e n~ao em seres humanos, e como isso pode se
correlacionar com novos tratamentos de c^ancer pedi atrico.
Mais de 16 mil criancas e adolescentes s~ao diagnosticados com c^ancer
todos os anos nos Estados Unidos, enquanto entre elefantes, praticamente
n~ao h a incid^encia da doenca ao longo de toda a vida do animal. Dr.
Schiffman; Dr. Dennis Schmitt, chefe de Servicos Veterin arios e diretor
de Pesquisa do Ringling Bros. and Barnum & Bailey; e Dr.
Wendy Kiso, cientista de Pesquisa e Conservac~ao do Ringling Bros.
Center for Elephant Conservation; entre outros colaboradores
cientistas em suas equipes, confirmaram recentemente que os elefantes
raramente desenvolvem c^ancer, com uma taxa de mortalidade inferior a 5%.
Para efeito de comparac~ao, a mesma taxa entre humanos e de 25%. Ao
estudarem o genoma dos elefantes, eles descreveram que esses animais
possuem 40 c opias de um gene supressor de tumor chamado TP53,
enquanto os seres humanos t^em somente duas c opias.
Trabalhando com o Jardim Zool ogico Hogle de Utah e o Ringling Bros.
Center for Elephant Conservation, Dr. Schiffman e seus colegas
estudaram a reac~ao do sangue de elefantes a agentes de danificac~ao de
DNA e descobriram que a c elula do animal sofre morte celular mais
rapidamente quando comparada com as celulas humanas. Dr. Schiffman
acredita que pode ser por isso que os elefantes desenvolvem menos c^ancer
do que os seres humanos. As descobertas completas do estudo foram
publicadas na nova edic~ao do Journal
of American Medical Association.
A aplicac~ao de pesquisa translacional sobre o c^ancer – as descobertas
provenientes da ci^encia b asica que melhoram a sa ude e o bem-estar
humanos aperfeicoando pr aticas m edicas e de enfermagem, e criando
resultados de sa ude significativos – poderia pavimentar o caminho rumo a
uma fronteira inteiramente nova para a pesquisa e o tratamento do
c^ancer, da mesa do laborat orio ao leito do paciente.
A fam ilia Feld est a formando o Ringling Bros. Children’s Fund™
como um elemento de sua filantropia cont inua atrav es da Feld Family
Foundation para apoiar iniciativas beneficentes para as criancas. Como
parte da parceria com o Primary Children’s Hospital, o Departamento de
Pediatria e Dr. Schiffman, o Ringling Bros. Children’s Fund e
o Ringling Bros. and Barnum & Bailey ir~ao doar mais de
US$ 1 milh~ao em apoio `a pesquisa sobre o c^ancer e ao atendimento de
criancas.
Nas pr oximas 50 cidades visitadas pelo Ringling Bros. and Barnum
& Bailey , a Ringling Bros. ir a doar US$ 10 mil a um
hospital infantil ou centro de tratamento local, e o Ringling
Bros. Children’s Fund ir a equiparar cada doac~ao com uma doac~ao
adicional de US$ 10 mil `a Primary Children’s Hospital Foundation em
apoio a seu Programa de Pesquisa sobre o C^ancer Pedi atrico. Esse
programa, que ajudou a apoiar a pesquisa com elefantes, concentra-se em
novas abordagens de prevenc~ao e diagn ostico, e na melhoria do valor do
tratamento contra o c^ancer pedi atrico.
Informac~oes adicionais sobre o Ringling Bros. and Barnum & Bailey
e o Ringling Bros. Center for Elephant Conservation, a parceria e
tamb em sobre como as fam ilias podem fazer doac~oes `a pesquisa podem ser
encontradas na internet em .ringling.com
e .ringlingelephantcenter.com.
NOTA DO EDITOR: Informac~oes
complementares para apoiar a reportagem est~ao anexas e podem ser
encontradas tamb em aqui.
Sobre a Feld Entertainment
A Feld Entertainment e a l ider mundial em turn^es de produc~ao e
apresentac~ao ao vivo, dedicadas a experi^encias de entretenimento
familiar que eleva o esp irito humano e cria mem orias inesquec iveis, com
30 milh~oes de espectadores em suas apresentac~oes a cada ano. As
produc~oes da Feld Entertainment j a estiveram at e hoje em mais de
75 pa ises e nos seis continentes e incluem Ringling Bros. and
Barnum & Bailey®, Monster Jam®,
Monster Energy Supercross, AMSOIL Arenacross, Disney On
Ice apresentada por Stonyfield YoKids Organic Yogurt, Disney Live!
Apresentada por Stonyfield YoKids Organic Yogurt e Marvel Universe LIVE!
Mais informac~oes sobre a Feld Entertainment podem ser encontradas em .feldentertainment.com.
Mais informac~oes sobre o Ringling Bros. Center for Elephant
Conservation est~ao dispon iveis em .ringlingelephantcenter.com.
Sobre o Primary Children’s Hospital
O Primary Children s Hospital e o unico hospital infantil de servicos
integrais para Utah, Idaho, Wyoming, Nevada e Montana, prestando
atendimento a criancas com as mais complexas les~oes e enfermidades,
incluindo as que necessitam de transplante de corac~ao, f igado, rim e
medula ossea. O Primary Children’s e o unico Centro de Trauma Pedi atrico
de N ivel 1 na regi~ao Intermountain West. O hospital e de propriedade da
Intermountain Healthcare, um sistema de assist^encia `a sa ude sem fins
lucrativos, e e afiliado `a Escola de Medicina da Universidade de Utah,
que re une pesquisa, treinamento e tratamento de excel^encia para oferecer
a melhor assist^encia `a sa ude para as criancas. As doac~oes s~ao
administradas pela Primary Children’s Hospital Foundation, uma
instituic~ao beneficente incorporada separadamente sob o c odigo IRS
501(c)(3). A fundac~ao apoia as metas do hospital de oferecer assist^encia
pedi atrica do mais alto n ivel em uma atmosfera de amor e cuidado.
Sobre o Departamento de Pediatria da Universidade de Utah
O Departamento de Pediatria e o segundo maior departamento da Escola de
Medicina da Universidade de Utah e um dos maiores departamentos
pedi atricos dos EUA. Ele possui mais de 270 membros docentes, com uma
distribuic~ao equitativa entre homens e mulheres, e tem o maior n umero de
docentes titulares mulheres da Escola de Medicina. O departamento e
composto de 22 divis~oes m edicas e programas, que operam em conjunto com
quatro iniciativas principais: educac~ao, pesquisa, cl inica e acad^emica.
Suas divis~oes fornecem um conjunto completo de especialidades e
subespecialidades de servicos pedi atricos para criancas de toda a regi~ao
de Intermountain West.
Sobre o Huntsman Cancer Institute da Universidade de Utah
O Huntsman Cancer Institute (HCI) e um dos maiores centros de pesquisa
acad^emica e tratamento de c^ancer do mundo. O HCI gerencia o Banco
de Dados da Populac~ao de Utah , a maior base de dados gen etica do
mundo, com mais de 16 milh~oes de registros vinculados a genealogias,
registros de sa ude e estat isticas vitais. Utilizando esses dados, os
pesquisadores do HCI j a identificaram v arios genes causadores de c^ancer,
incluindo aqueles respons aveis por melanoma, c^ancer de colo do utero,
c^ancer de mama e paraganglioma. O instituto e membro da National
Comprehensive Cancer Network (uma alianca composta de 26 centros de
c^ancer l ideres mundiais) e e um National
Cancer Institute-Designated Comprehensive Cancer Center. O HCI trata
pacientes com todas as formas de c^ancer e opera diversas cl inicas de
alto risco dedicadas ao c^anceres de pele, mama, colo do utero e
p^ancreas. O Centro de Aprendizagem sobre o C^ancer do HCI, voltado `a
formac~ao de pacientes e do p ublico em geral, cont em um dos maiores
acervos de publicac~oes sobre c^ancer dos EUA. O nome do instituto e uma
homenagem a Jon
M. Huntsman, um filantropo, industrial e sobrevivente do c^ancer de
Utah.
O texto no idioma original deste an uncio e a vers~ao oficial autorizada.
As traduc~oes s~ao fornecidas apenas como uma facilidade e devem se
referir ao texto no idioma original, que e a unica vers~ao do texto que
tem efeito legal.
05 October 2015
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