Pivotal Phase III Trial Showed Promacta (eltrombopag olamine)
Raised Platelet Counts and Reduced Bleeding in Patients With
VIENNA, Austria, June 11, 2007 /PRNewswire/ -- GlaxoSmithKline
plc announced results from an international, pivotal Phase III
study of its investigational non-peptide oral platelet growth
factor, PROMACTA(R) (eltrombopag olamine). Data from this study
showed that PROMACTA
at 50-75mg once daily res...
GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP
...ne or more prior ITP therapies. Patients
were eight times more likely than those on placebo... treatments that can
help improve patients' lives. promacta
is a great example of this commitment."
received accelerated approval from the FDA on Nove...
FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
...ctomy. The approval is a significant milestone for promacta
and the ITP community, as promacta
is the first oral thrombopoietin (TPO) receptor ag...d for adult patients with chronic ITP. GSK expects promacta
to be available by the next week.
"It is ...
FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
idiopathic thrombocytopenic purpura (ITP). promacta
is an investigational,
once-daily oral treatment t...dence of bleeding in chronic ITP.
If approved, promacta
would be the first oral thrombopoeitin (TPO)
recep...elet counts and reduce bleeding.
"Our goal for promacta
is to make available a targeted therapy in oral
Long-Term Safety and Efficacy Data on Promacta(TM) (Eltrombopag) Presented at American Society of Hematology Annual Meeting
...Hematology, December 8-11 2007 in Atlanta, GA.
is an investigational compound that has not receiv...in any market for any indication at this time.
was generally well tolerated in this study. Of the...ITP in the U.S.(5) and a
similar number in Europe. promacta
is an investigational oral, non-peptide,
Lancet study supports new, highly effective treatment for blood disorder
...d, rarely, life-threatening brain hemorrhages.
(eltrombopag) was granted accelerated approval by ...y testing period, 59 percent of subjects receiving promacta
achieved platelet counts at or over 50,000 per L o...count is between 30,000 and 50,000 per L of blood. promacta
subjects were almost 10 times more likely to reach...
Eltrombopag effective for hepatitis C patients with low blood-platelet counts
...orts equity ownership in the company.)
The current study was sponsored by GlaxoSmithKline, which is developing eltrombopag. Eltrombopag (marketed as promacta
in the U.S. and Revolade in Europe) is an investigational oral, non-peptide platelet growth factor that induces the proliferation and differentiation ...