According to the Vasculitis Foundation, the disease formerly known as Churg-Strauss syndrome and now referred to by its medically more accurate term, eosinophilic granulomatosis with polyangiitis (EGPA), is a rare autoimmune disease that causes systemic vasculitis (inflammation in the wall of blood vessels of the body) that can be life-threatening.
The National Institutes of Health says that EGPA is characterized by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small- to medium-sized blood vessels. The inflamed vessels can affect various organ systems including the lungs, gastrointestinal tract, skin, heart and nervous system. It is an extremely rare disease, with an estimated 2 new cases per 1 million people diagnosed each year, and an overall prevalence of 10 to 14 per 1,000,000 adults.
The FDA today expanded the approved use of Nucala (mepolizumab) from GlaxoSmithKline (NYSE: GSK) to treat adult patients with EGPA, providing the first approved therapy specifically to treat EGPA. Standard of care historically has involved a combination of corticosteroids and immunosuppressants.
Prior to today’s action, patients with this challenging, rare disease did not have an FDA-approved treatment option. The expanded indication of Nucala meets a critical, unmet need for EGPA patients. It’s notable that patients taking Nucala in clinical trials reported a significant improvement in their symptoms.
– Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Nucala was previously approved by the FDA in 2015 to treat patients age 12 years and older with a specific subgroup of asthma (severe asthma with an eosinophilic phenotype) despite receiving their current asthma medicines. Nucala is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) produced by recombinant DNA technology in Chinese hamster ovary cells.
Patients with EGPA often suffer from recurrent relapses that place them at greater risk of permanent tissue and organ damage. Clinical data demonstrated that mepolizumab increased accrued time in remission, reduced the frequency of relapse and flares, and enabled patients to have their dose of corticosteroid reduced compared to placebo in patients already receiving standard of care. These are key treatment goals and this approval is an important milestone both for treating physicians and for patients.
– Dr. Michael E. Wechsler, Professor of Medicine at National Jewish Health and Principal Investigator of the pivotal clinical study.
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