The FDA expands the indications of GSK’s Nucala (mepolizumab) to include eosinophilic granulomatosis with polyangiitis (EGPA), a rare asthmatic condition.
GSK’s antibody drug Nucala (mepolizumab) is now available for patients suffering from EGPA, a very rare form of asthma driven by inflammation. The FDA approval is based on data from a 52-week Phase III trial that showed that the drug reduced the frequency of relapse and flares and enabled patients to reduce their corticosteroid use.
With 136 participants, it’s the largest study conducted in EGPA to date according to Eric Dube, Head of GSK’s Global Respiratory Franchise. He added that “now for the first time physicians have a targeted treatment option for this debilitating condition.”
Nucala is approved since 2015 to treat severe eosinophilic asthma, making £102M in sales in 2016. This new approval might give GSK a small boost against the competition, which is getting tight. AstraZeneca’s Fasenra, Teva’s Cinqair and Novartis’ Xolair are all fighting with Nucala for a bite of the respiratory disease market, expected to be worth over €35Bn by 2023.
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