Glaxo's Nucala Label Expansion Application Gets FDA Approval
Zacks Investment Research | Dec 12, 2017 09:40PM ET
GlaxoSmithKline plc (NYSE:GSK) announced that the FDA has approved the label expansion of eosinophilic asthma drug, Nucala, to include treatment of eosinophilic granulomatosis with polyangiitis ("EGPA"). With this approval, Nucala becomes the first targeted treatment for EGPA, which was previously known as Churg-Strauss syndrome.
EGPA is a rare autoimmune disease, which causes inflammation in small and medium-sized blood vessels. It can cause damage to lungs, sinuses, skin, heart, gastrointestinal tract, nerves and other organs.
Nucala is presently approved for treating severe eosinophilic asthma.
Shares of Glaxo have decreased 7.8% so far this year, underperforming the industry ’s gain of 17.4% in that period.
Coming back to the news, the FDA approved the label expansion based on data from the phase III study – MIRRA – which evaluated a dose of 300mg of Nucala as an add-on therapy to standard of care in relapsing and/or refractory EGPA versus placebo.
Data showed that Nucala achieved statistically significant improvement in primary endpoints – accrued time in remission and proportion of patients achieving remission – compared to placebo.
According to principal investigator of MIRRA study, Dr. Michael Wechsler, EGPA patients often suffer from recurrent relapses, which may permanently damage tissue and organ. Data from the study has shown that Nucala has increased accrued time in remission and also reduced the frequency of relapse and flares. The patients were also able to reduce their dose of corticosteroid compared to placebo.
Currently, approved treatments for EGPA generally work by reducing active inflammation and by suppressing the body’s immune response.
A supplemental biologics license application for label expansion of Nucala to include treatment of chronic obstructive pulmonary disease is under review in the United States.
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