U.S. Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood-related cause of the disease.
Hypereosinophilic Syndrome (HES): A heterogeneous group of rare disorders associated with persistent eosinophilia with evidence of organ damage.
Symptoms: Skin rashes, itching, asthma, difficulty breathing, abdominal pain, vomiting, diarrhea, arthritis, muscle inflammation, congestive heart failure, deep venous thrombosis and anemia.
Most Common Side Effects of Nucala: Upper respiratory tract infection and pain in extremities (such as the hands, legs, and feet).
Nucala should not be administered to patients with a history of hypersensitivity to mepolizumab or one of its ingredients.
Herpes zoster (shingles) infections have occurred in patients receiving Nucala. Health care providers should consider vaccination if medically appropriate.
FDA is granting approval to GlaxoSmithKline of Research Triangle Park, North Carolina.
Nucala is also FDA-approved for patients aged 6 years and older with severe asthma with an eosinophilic phenotype and for adult patients with eosinophilic granulomatosis with polyangiitis, a rare autoimmune condition that causes blood vessel inflammation.