The US Food and Drug Administration (FDA) has approved Octapharma USA’s Octagam 10% for treatment of adults with chronic immune thrombocytopenic purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding.

Octagam 10% [immune globulin intravenous (human) 10% (100mg/ml) liquid preparation] rapidly raises platelet counts to control or prevent bleeding in chronic ITP patients.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

US approval of Octagam 10% is supported by data from an Octapharma-sponsored clinical trial that assessed the safety and efficacy of Octagam10% in 66 chronic ITP patients aged between 17 and 88 years.

"The company is expected to launch Octagam 10% in the US in September."

Headache, fever, and increased heart rate were the most common treatment-related adverse events observed with Octagam 10% treatment during the clinical trial.

The company is expected to launch Octagam 10% in the US in September.

Octapharma USA president Flemming Nielsen said: "The FDA approval of Octagam 10% represents a significant Octapharma milestone, but, more importantly, opens up new treatment options for patients.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"Octagam 10% has demonstrated safety and efficacy in a pivotal clinical trial.

"Octapharma looks forward to providing the product in the US, further advancing our vision of providing patients with therapies to treat life-threatening conditions."

An intravenous immunoglobulin 10% formulation, Octagam 10% is a solvent/detergent treated, sterile preparation of highly purified immunoglobulin G derived from large pools of human plasma.

Octapharma USA has been marketing Octagam 5% [immune globulin intravenous (human) 5% (50 mg/ml) liquid preparation] since 2004 for the treatment of primary humoral immunodeficiency.