31st Mar 2014 11:57
LONDON (Alliance News) - GlaxoSmithKline PLC said Monday that it has withdrawn its marketing authorisation application for its advanced ovarian cancer maintenance therapy Votrient in the EU.
The application was in relation to an additional indication of the treatment of women with FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer who had not progressed after receiving first-line chemotherapy.
The company said it had decided to pull the application because data from the planned second interim analysis of the phase III study of Votrient did not support an overall positive benefit-risk for this use.
"While we are disappointed by these results, we will progress additional analyses which may add to the body of scientific evidence in this disease setting," said Head of Oncology Research and Development Rafael Amado.
It was the second piece of bad news from Glaxo Monday.
In a separate statement, Glaxo said its Phase III STABILITY study for darapladib in the treatment of patients with chronic coronary heart disease failed to meet its primary endpoint, although it said that the effects of the drug on the reduction of coronary events was of potential interest.
The pharmaceutical giant also Monday announced plans to invest up to GBP130 million in Africa over the next five years, producing 500 jobs, and plans to train and up skill 10,000 community healthcare workers across Kenya, Ghana and Nigeria over the next three years.
Shares in Glaxo were trading down 0.9% at 1,604.39 pence Monday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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