Please login to the form below

Not currently logged in
Email:
Password:

GSK's Promacta granted full US approval

The US Food and Drug Administration has granted approval to GSK's Promacta, used to raise platelet counts in patients with a rare blood disorder

The US Food and Drug Administration (FDA) has granted full marketing approval to GlaxoSmithKline's (GSK) Promacta (eltrombopag), an oral tablet that is used to raise platelet counts in patients with a rare blood disorder.

Promacta, which was granted provisional clearance under the agency' accelerated approval programme in late 2008, is approved for patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Chronic ITP is a serious disease marked by increased platelet destruction and/or inadequate platelet production in the blood, leading to an increased risk of bruising and bleeding.

"Promacta is a testament to how the FDA Accelerated Approval Programme supports development of therapies that meet unmet patient needs," said Steven Stein, vice president of Medicines Development at GSK. "Patients with limited treatment options gained access to Promacta while GSK conducted clinical studies that yielded additional efficacy and safety data."

Promacta's labelling is being updated to include efficacy and safety data from a six- month study showing that patients treated with the drug were significantly more likely to achieve the study's targeted platelet count during the entire six-month period than were the patients on placebo.

Promacta was discovered as a result of a research collaboration between GSK and Ligand Pharmaceuticals. GSK developed the product and has exclusive worldwide rights, with Ligand standing to receive milestone payments and royalties.

In May 2010, GSK halted a study of the drug in patients with thrombocytopaenia related to chronic liver disease after the treatment was linked to an increased risk for portal venous thrombosis in that population.

28th February 2011

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Bedrock Group

Bedrock Healthcare Communications is a privately owned, award winning communications agency that creates and delivers highly effective, insight driven medical...

Latest intelligence

Good design saves lives
Good design and creative thinking are essential if we are to improve on existing problems in new ways, which is why design and creativity within healthcare is vital. Health is...
Why you must understand the pricing of patient recruitment companies
Recruiting a diverse range of patients and engaging with them for your clinical trial isn’t an easy task, which means you might turn to patient recruitment companies, like us, who...
wearable health tech
A cultural shift in clinical research
Research organisations across the board are experimenting with new technologies...

Infographics