Skip to Content

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

DateArticle
Nov  4, 2015Approval FDA Approves Nucala (mepolizumab) to Treat Severe Asthma
Jun 11, 2015GSK Announces Outcome of US FDA Advisory Committee Recommending Approval of Mepolizumab for Severe Asthma
Nov  5, 2014GSK Announces Regulatory Submissions for Mepolizumab in Severe Eosinophilic Asthma
Sep  8, 2014NEJM and ERS publish positive results from GSK phase III studies of mepolizumab
Mar 12, 2014GSK announces positive results from phase III studies for mepolizumab in severe eosinophilic asthma

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide