Nucala® (mepolizumab)

BL 125526

Nucala® (mepolizumab)

BL 125526

U.S. License Holder:

GlaxoSmithKline LLC

Date of License:

November-04-2015

Last Update:

May-15-2022

approved_indications FDA-Approved Indications

NUCALA (mepolizumab) is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for:

Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype;

Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP);

The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA);

The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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