United States: USFDA's First Drug Approval For The Treatment Of Eosinophilic Granulomatosis With Polyangiitis (Formerly Known As Churg- Strauss Syndrome)

On December 12, 2017, the U.S. Food and Drug Administration expanded the approved use of Nucala (mepolizumab) to treat adult patients with Eosinophilic Granulomatosis with PolyAngiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy - specifically to treat EGPA. The approval of Nucala is granted to GlaxoSmithKline on the basis of clinical trial data spanning 52-weeks , which showed that patients receiving 300 mg of Nucala achieved a significantly greater accrued time in remission compared to the patients receiving placebo³².

About Eosinophilic Granulomatosis with Polyangiitis (EGPA)

According to the National Institute of Health (NIH)³³, EGPA is a rare condition characterized by asthma with high levels of eosinophils (a type of white blood cells that help fight infection), and inflammation of small- to mediumsized blood vessels. The inflamed vessels can affect various organ systems including the lungs, gastrointestinal tract, skin, heart and nervous system. The exact cause of eosinophilic granulomatosis with polyangiitis is unknown, but it is thought to be an autoimmune disorder. It is estimated that approximately 0.11 to 2.66 new cases per million people are diagnosed each year, with an overall prevalence of 10.7 to 14 per million adults.

About Mepolizumab (Nucala)

Nacula is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) produced by recombinant DNA technology in the ovarian cells of Chinese hamster. It is a targeted biological therapy developed to treat diseases which are driven by inflammation linked to higher-than-normal eosinophils being present in the blood.

Nucala was previously approved in 2015 to treat patients age 12 years and older with a specific subgroup of asthma (severe asthma with an eosinophilic phenotype) in addition to their current asthma medicines. At present, Mepolizumab 100mg is approved for the treatment of patients with severe eosinophilic asthma in over 40 countries including the EU, US and Japan and has been prescribed to over 18,000 patients in the US. Mepolizumab 300mg is now approved in the US for the treatment of adult patients with EGPA. Nucala is administered subcutaneously into the upper arm, thigh or abdomen once in every four weeks by a health care professional³⁴.

Footnotes

 32 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588594.htm

33 https://rarediseases.info.nih.gov/diseases/6111/eosinophilic-granulomatosis-with-polyangiitis

34 https://www.gsk.com/en-gb/media/press-releases/gsk-achieves-approval-for-nucala-mepolizumab-for-the-treatment-of-eosinophilic-granulomatosis-with-polyangiitis-egpa-for-adults-in-the-us/

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