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GSK preps COPD filing for asthma pioneer Nucala

Moves despite reporting mixed data for the treatment earlier this year

GlaxoSmithKline GSK

GlaxoSmithKline is moving swiftly ahead with plans to file interleukin-5 inhibitor Nucala in chronic obstructive pulmonary disease (COPD), in hope of extending use of the drug beyond severe asthma.

The company plans filings for Nucala (mepolizumab) before the end of the year as an add-on therapy in COPD characterised by high levels of inflammatory cells called eosinophils, a particularly high-risk form of the disease, despite reporting mixed data with the drug earlier this year.

In the METREX trial, Nucala hit its objective of reducing moderate to severe exacerbations, cutting them by 18% compared to placebo, which just about achieved statistical significance. A second trial – called METREO – showed that the drug reduced exacerbations by 14%-20%, depending on the diose, which was not a significant difference to the control group.

GSK's decision to press ahead with regulatory filings on what could be regarded as a somewhat shaky footing, but the company says a meta-analysis of the two trials – published in the New England Journal of Medicine (NEJM) – suggests a greater treatment effect for Nucala as the level of eosinophils in the trial patients increased.

The company thinks this could serve as a biomarker that would allow Nucala to be directed towards those COPD patients most likely to benefit from treatment with the drug, and may be hoping that the lack of effective therapies for COPD exacerbations – a sudden worsening of symptoms – will made weigh in Nucala's favour.

GSK may be able to convince regulators of the merits of that approach, but the decision to press on could also reflect that the company is struggling with a thin pipeline, at least outside of its buoyant HIV unit ViiV Healthcare - and needs to squeeze every drop of potential out of its new products while it tries to build up its R&D prospects.

Under new CEO Emma Walmsley, the UK-based group has been jettisoning peripheral R&D projects and withdrawing from some R&D areas, such as rare diseases, so as to concentrate its spending in priority areas such as cancer.

Aside from Nucala, GSK is pinning its near-term hopes on dolutegravir-based HIV therapies and its closed triple therapy for COPD – delivering inhaled corticosteroid (ICS) fluticasone furoate, long-acting beta agonist (LABA) vilanterol and long-acting muscarinic antagonist (LAMA) umeclidinium – and shingles vaccine Shingrix which is up for an FDA advisory committee meeting later today.

Meanwhile, it is pitching Nucala at as many indications as it can, filing for approval of the drug in June as add-on therapy to corticosteroids for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare disorder characterised by widespread inflammation in the walls of small blood vessels.  It has also started trials of the drug in severe nasal polyposis.

GSK reported sales of £132m ($175m) for Nucala in the first half of the year, up from £105m in the same period of 2016, and the company needs to rack up additional indications for the drug if it is to meet analysts' projections of $1bn-plus in peak sales.

Article by
Phil Taylor

13th September 2017

From: Regulatory

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