(Alliance News) - GSK PLC on Monday received a double-dose of good news with its Nucala and Blenrep products receiving positive indications from industry regulators.
GSK shares were up 0.6% to 1,352.00 pence early Monday in London. The wider FTSE 100 index was up 0.3%.
The London-based pharmaceuticals firm said the US Food & Drug Administration has accepted for review data from a study on its Nucala drug as a treatment for chronic obstructive pulmonary disease.
The drug maker said Nucala could be the first approved biologic treatment with monthly dosing for COPD sufferers.
Data from the 'Matinee' study has been accepted to "support the regulatory review process" in GSK's pursuit for the new approval for Nucala, the brand name of mepolizumab.
"The Matinee study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy, achieving a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks," GSK explained.
Nucala is not currently an accepted treatment for COPD anywhere in the world.
In addition, GSK said its Blenrep drug has been approved for priority review in China to treat sufferers of myeloma, a bone marrow cancer.
The regulatory submission is supported by phase III head-to-head Dreamm-7 trial showing statistically significant efficacy, including overall survival.
GSK said it is the seventh major regulatory filing acceptance this year for Blenrep, the brand name of belantamab mafodotin, combinations in this indication, following US filing acceptance based on Dreamm-7 and Dreamm-8.
"Today's regulatory filing acceptance, with a priority review, is a meaningful step forward in our efforts to bring the benefits of Blenrep in combination to patients in China. Multiple myeloma patients need new options that may improve outcomes, particularly at first relapse," said Hesham Abdullah, GSK's global oncology head.
By Jeremy Cutler, Alliance News reporter
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