Nucala Approval History
- FDA approved: Yes (First approved November 4th, 2015)
- Brand name: Nucala
- Generic name: mepolizumab
- Dosage form: Injection
- Company: GlaxoSmithKline
- Treatment for: Asthma
Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma.
FDA Approval: The safety and efficacy profile of Nucala was established in three placebo‑controlled trials. Compared with placebo, patients receiving Nucala had fewer severe asthma attacks (exacerbations) and greater reductions in their daily maintenance oral corticosteroid dose.
Mechanism: Nucala inhibits interleukin-5 and reduces the levels of blood eosinophils, a type of white blood cell that contributes to the development of asthma.
Administration: Nucala is given via subcutaneous injection every four weeks.
Side Effects: The most common side effects of Nucala include headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness (fatigue).
Additional Information: Hypersensitivity reactions can occur within hours or days of being treated with Nucala. Herpes zoster infections (shingles) have occurred in patients receiving Nucala, and at-risk patients should consider vaccination before commencing treatment.
Development History and FDA Approval Process for Nucala
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