With data in hand, GSK readies to expand Nucala label
- GlaxoSmithKline's eosinophil targeting asthma drug, Nucala (mepolizumab), has met its primary and secondary endpoints in a pivotal 52-week Phase 3 trial for a new potential indication, eosinophilic granulomatosis with polyangiitis (EGPA). The drug performed better than placebo on all endpoints, in results announced pre-Thanksgiving.
- In patients with relapsing and refractory EGPA, 28% treated with Nucala went into remission for at least 28 weeks, compared with 3% receiving placebo. At both 36 and 48 weeks, 32% treated with Nucala went into remission, compared with 3% of the placebo patients. There was one death during the trial but this wasn't deemed to be drug related.
- EGPA, also known as Churg-Strauss syndrome, is a rare disease affecting around 14-45 people per million. GSK plans to submit Nucala for approval for EGPA in 2017.
GlaxoSmithKline's biologic, Nucala (mepolizumab) is an anti-IL-5 monoclonal antibody and acts by targeting eosinophils. It is approved worldwide as an asthma drug, but this is an increasingly busy area, as other drugs targeting eosinophils enter the market, such as AstraZeneca's benralizumab, which has cleared Phase 3 trials and Teva's Cinqair/Cinqaero (reslizumab), launched in the U.S. and Europe.
EGPA is a rare disease caused by inflammation in blood vessel walls. It can affect the heart, lungs, skin, gastrointestinal tract, kidneys and nervous system, and it can be life-threatening. While symptoms vary, almost all people with EGPA have asthma and/or nasal sinus polyps and blood eosinophilia.
So, while EGPA affects a small population, it provides new options for Nucala sales, as treatment options are limited, and include corticosteroids and immunosuppressants with their associated long term adverse effects.
"Given that patients with this rare systemic inflammatory disease have limited treatment options, these results represent a significant step forward in our efforts to help them. We now look forward to progressing our regulatory submission plans," said Steve Yancey, VP and Medicine Development Lead for mepolizumab at GSK.
AstraZeneca is exploring other eosinophil-driven indications to further expand the label of the drug, including nasal polyposis, hypereosinophilic syndrome and severe atopic dermatitis, all in Phase 2.
- GlaxoSmithKline Statement
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