Posted from: Tuesday, January 16, 2018 - 01:04 PM - Present

New Indication for Nucala to Treat EGPA

December 12, 2017 – The U.S. FDA has approved a new indication for Nucala® (mepolizumab), manufactured by GlaxoSmithKline, to treat eosinophilic granulomatosis with polyangiitis (EGPA). Nucala is the first drug to be approved by the FDA specifically for treatment of EGPA.

Formerly known as Churg-Strauss syndrome, EGPA is a rare autoimmune disorder that can be difficult to treat. Characteristics of the disease include inflammation of blood vessel walls (vasculitis), asthma, and high levels of eosinophils, a type of white blood cell implicated in inflammatory responses when overproduced. Vasculitis caused by EGPA can affect multiple organ systems, including the heart, lungs, gastrointestinal tract, skin, and nervous system. Patients with EGPA may experience recurrent relapses, which raises their risk of lasting tissue damage. In a clinical study, Nucala was found to help decrease the frequency of relapses, increase the length of time spent in remission, and allow patients to reduce their corticosteroid use, compared to patients who received a placebo in combination with standard therapies.

The U.S. FDA originally approved Nucala in 2015 to provide maintenance treatment, when used in combination with other asthma medications, for severe asthma in patients at least twelve years of age. An interleukin-5 (IL-5) antagonist, the drug works by reducing production of eosinophils. Recommended dosing for EGPA is 300mg once every four weeks via three separate 100mg subcutaneous injections.

Nucala is currently available in 100mg single-dose vials for reconstitution, and must be administered by a healthcare professional. Patient assistance programs are available from GlaxoSmithKline.

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Last Updated Monday, September 16, 2019 - 06:50 PM.