Octapharma submits BLA to US FDA for octagam 10%

Switzerland's Octapharma says it has recently submitted its Biological License Application for octagam 10% (human normal intravenous immunoglobulin, liquid) to the US Food and Drug Administration with the goal of expanding the biopharmaceutical company's US immune globulin therapy portfolio by early 2010. The application was submitted for the treatment of idiopathic thrombocytopenic purpura (ITP), a blood-clotting disorder that can result in
excessive bruising and bleeding.

"We are extremely pleased with the BLA submission for octagam 10% and look forward to advancing Octapharma's firm commitment to providing immune globulin therapy in the US marketplace," said Octapharma USA president Flemming Nielsen. "The expected introduction of octagam 10% will provide yet another immune globulin intravenous (IGIV) product option for patients that further builds on the success already achieved with the octagam product line both globally and in the USA," he added.

In 2004, Octapharma, one of the largest plasma products manufacturers in the world, gained approval from the FDA for its IGIV product, octagam (immune globulin intravenous [human] 5%). The therapy, which treats disorders of the immune system, has already gained over 10% of the US market, despite entrenched competition, the Swiss firm said. "No market is more important to Octapharma than the USA," said Mr Nielsen. "

Octapharma also recently submitted an Investigational New Drug  application for a next generation IGIV product for the treatment of ITP and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder that progressively impairs leg and arm function.

The IND for this next generation IGIV is just one part of Octapharma's extensive global R&D program. The company is also evaluating the efficacy of immune globulin as a treatment in new and existing conditions. Octagam is currently being investigated in clinical trials studying the efficacy of treatment for CIDP, ITP, multiple sclerosis, Alzheimer's disease and primary immune deficiency. In February, Octapharma started Phase II clinical trials following FDA review of its IND for octagam 10% in mild-to-moderate Alzheimer's disease.