ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:

Dictionar de medicamente online

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Dictionar medical online

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Puteti trimite articole cu tema medicala la
adresa de email

Solutie antistress!
Construieste poduri :)
Joc, Construieste podul, Cargo Bridge

Prinde pisica neagra :)
Prinde pisica neagra- Chat Noir - Flash game

GlaxoSmithKline Files For FDA Approval Of Promacta/ Revolade (eltrombopag) To Be The First Oral Platelet Growth Factor For Rare Blood Disorder

GlaxoSmithKline (GSK) announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for approval to market PROMACTATM/REVOLADETM (eltrombopag). If approved, eltrombopag would be the first oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding. Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding.1,2 Eltrombopag is an investigational, once-daily oral treatment that induces the proliferation and differentiation of cells in the bone marrow to produce platelets.

"Patients with chronic ITP do not have a treatment option that offers the convenience of an oral platelet growth factor," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "GSK is pleased with the data provided to support the NDA and hopeful that, if approved, PROMACTA/REVOLADE may provide physicians and chronic ITP patients with a new, convenient and effective option for treating this difficult disease."

GSK also plans to submit a Marketing Authorisation Application (MAA) for eltrombopag in Europe in 2008.

About the Data Submitted

The NDA submission is supported by the largest database of clinical trial information on investigational therapies for chronic ITP patients. Two pivotal trials, one Phase III trial and one Phase II trial, were submitted to support the NDA submission.

About the Phase III Data3

The Phase III study was an international, randomised, double-blind, placebo-controlled trial that enrolled 114 adults with chronic ITP and baseline platelet counts of 50,000/uL after up to six weeks of therapy. An endpoint of 50,000/µL was selected because at a platelet count of >50,000/µL patients have a low risk of bleeding and bruising. Eligible patients must have had a platelet count 50,000/µL. Importantly, there was a significantly lower incidence of bleeding during treatment with eltrombopag compared to placebo (p=0.029). Clinically significant serious bleeding was observed in fewer eltrombopag patients (16%) than placebo patients (36%). The most common adverse event (AE) observed in this study was headache, reported in 8% and 11% of patients receiving eltrombopag and placebo respectively. Other common AEs occurring in at least 5% of eltrombopag patients included nausea, nasopharyngitis, diarrhoea and vomiting.

About the Phase II Data4

The Phase II study was a multicentre, randomised, double-blind, placebo-controlled trial examining once daily oral dosing of eltrombopag. One hundred and eighteen adults with chronic ITP and platelet counts





GlaxoSmithKline fiºiere pentru aprobarea FDA Promacta / Revolade (eltrombopag) Pentru a fi primul oralã trombocitelor factor de creºtere Pentru Rare Blood tulburãri - GlaxoSmithKline Files For FDA Approval Of Promacta/ Revolade (eltrombopag) To Be The First Oral Platelet Growth Factor For Rare Blood Disorder - articole medicale engleza - startsanatate