Industry Trend Analysis - Rewards For Expanded Nucala Indication Will Be Small For GSK - FEB 2018

BMI View: This expanded approval targets a very small patient population of some 5,000 in the US, but will nonetheless bolster GlaxoSmithKline ' s respiratory disease portfolio and increase the firm ' s reputation with regard to niche autoimmune conditions. Revenues from this new indication will be small, as GSK is unlikely to be able to raise the price of Nucala for treating EGPA alone. However, for those with the condition, Nucala will prove to be essential.

The FDA has expanded the approved use of GlaxoSmithKline's Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. The Agency noted that this new indication provides the first FDA-approved therapy specifically to treat EGPA. GSK submitted its sBLA for the indication in June 2017.

According to the National Institutes of Health (NIH), EGPA (formerly known as Churg-Strauss syndrome) is a condition characterised by asthma, high levels of eosinophils, and inflammation of small- to medium-sized blood vessels. It is estimated that approximately 0.11 to 2.66 new cases per 1mn people are diagnosed each year, with an overall prevalence of 10.7 to 14 per 1,000,000 adults. This translates to approximately 5,000 patients with EGPA in the US. The mean age of diagnosis is 48 years, and the disease can be life-threatening for some patients. The FDA granted the application priority review and orphan drug designations.

Nucala Sales Small But Growing Fast
Quarterly Nucala Sales (GBPmn)
Source: GlaxoSmithKline, BMI

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