Posted on 17/06/2009 in Pharmaceutical Company Product News GlaxoSmithKline (GSK) has received a three-month biologic licence application (BLA) extension of three months for ofatumumab.
The medication is being developed along with Genmab. Authorisation for the treatment was originally submitted to the Food and Drug Administration (FDA) on January 30th 2009.
As part of its priority review, the regulatory body chose not to set the standard evaluation time of ten months, opting for six months instead.
The new action date for the BLA is now October 31st. It is hoped the extension will allow the FDA to analyse additional chemistry and manufacturing data about the medication that was submitted on June 5th.
On May 29th, the body's oncology drugs advisory committee voted in favour ten to three that the product was likely to be beneficial to those suffering chronic lymphocytic leukaemia.
GSK asserted it was committed to working with the FDA to ensure the medication could be available as a potential new treatment option to patients.
Earlier this month, the company announced results of a phase III clinical trial that demonstrated pazopanib could effectively reduce the risk of tumour progression or death in cancer sufferers by 54 per cent compared to a placebo.Other news stories from 17/06/2009
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