FDA Approves First Treatment for Rare Autoimmune disease
The US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). This is the first therapy to receive FDA approval to treat this rare autoimmune disease.
Nucala was originally approved in 2015 for the treatment of severe asthma with eosinophilic phenotype in patients aged 12 years or older. The therapy is administered as a subcutaneous injection once every 4 weeks by a health care professional.
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Approval for this new indication was based on data from a 52-week clinical trial, which demonstrated higher remission rates among patients who had received Nucala compared with placebo at weeks 36 and 48.
Common adverse effects include injection site reaction, back pain, headache, and fatigue. In addition, anaphylaxis, bronchospasm, hypotension, and herpes zoster infections have occurred.
Patients receiving Nucala should gradually discontinue treatment with systemic or inhaled corticosteroids.
FDA approves first drug for eosinophilic granulomatosis with polyangiitis, a rare disease formerly known as the Churg-Strauss syndrome [press release]. US Food and Drug Administration. December 12, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588594.htm. Accessed December 12, 2017.