Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves Nucala to Treat Vasculitis
FDA news release; 2017 Dec 12
The FDA has approved Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA).
Indications: Nucala is an interleukin-5 antagonist monoclonal antibody indicated for the treatment of adult patients with EGPA.
Dosage and administration: 300 mg as 3 separate 100-mg injections administered subcutaneously once every 4 weeks.
Efficacy and safety: Approval is based on results of a clinical trial showing that patients who received Nucala in addition to daily oral corticosteroids spent significantly more time in remission compared with patients who had placebo added to corticosteroid treatment. Additionally, more patients who took Nucala remained in remission for 1 year.
Side effects/risks: The most common adverse reactions are headache, injection site reaction, back pain, and fatigue.
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome [news release]. Silver Spring, MD: FDA. December 12, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588594.htm?utm_campaign=12122017_PR_FDA%20approves%20drug%20Eosinophilic&utm_medium=email&utm_source=Eloqua. Accessed December 18, 2017.
Nucala [package insert]. Philadelphia, PA: GlaxoSmithKline LLC, 2017. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL.PDF. Accessed December 18, 2017.
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Bosulif Approved to Treat Newly-Diagnosed Ph+ CML, Avillion news release; 2017 Dec 19
FDA Approves Nucala to Treat Vasculitis, FDA news release; 2017 Dec 12
FDA Approves Hemlibra to Prevent Bleeding, FDA news release; 2017 Nov 9
