Nucala - Mepolizumab

What is Nucala - Mepolizumab and what is it used for?

Nucala is an asthma medicine used to treat a particular type of asthma in adults, known as eosinophilic asthma. It is used in combination with other medicines in patients with severe asthma and not well controlled with previous treatments.

The active substance of Nucala is mepolizumab.

How is Nucala - Mepolizumab used?

Nucala must be prescribed by a doctor experienced in the diagnosis and treatment of severe eosinophilic asthma and can only be obtained with a prescription. It is available as a powder for the preparation of a solution for injection. The injection is given by a health worker under the skin in the upper arm, in the thigh or in the abdomen (belly) once every 4 weeks. The recommended dose is 100 mg. Nucala is intended for long-term treatment.

How does Nucala - Mepolizumab work?

The eosinophilic asthma symptomatology is associated with too high a count of eosinophils, a type of white blood cell, in the blood and in pulmonary mucus. The active ingredient in Nucala, mepolizumab, is a type of protein called a monoclonal antibody, capable of binding to a specific substance in the body. Mepolizumab binds to a substance known as interleukin-5, which promotes the production and survival of eosinophils. By binding to interleukin-5, mepolizumab blocks its action and, therefore, reduces the number of eosinophils. This helps reduce inflammation, resulting in reduced asthma attacks and improved symptoms.

What benefit has Nucala - Mepolizumab shown during the studies?

The benefits of Nucala in severe eosinophilic asthma not well controlled with previous treatment have been demonstrated in three main studies, in which it was compared with a placebo injection (a dummy drug). The first study involved 616 adults and adolescents, to whom Nucala was given every 4 weeks for a year, in addition to their regular asthma drug therapy. The second study involved 576 adults and adolescents, to whom Nucala was given every 4 weeks for 28 weeks. The main efficacy parameter in these studies was the number of severe attacks (exacerbations) of asthma that occurred during treatment, which decreased by about half in patients treated with Nucala.

The third study involved 135 patients with eosinophilic asthma severe enough to require regular oral (oral) therapy with corticosteroids (powerful anti-inflammatory drugs such as prednisone and prednisolone). The main efficacy parameter was the extent of corticosteroid dose reduction made possible by the use of Nucala for 24 weeks compared to placebo. More than half of the patients treated with Nucala (37 out of 69) were able to reduce their daily dose of corticosteroids by more than 50% up to a dose of 5 mg or less, while for 10 of them it was possible to completely stop corticosteroid therapy, compared with about a third of placebo-treated patients (22 of 66, of whom 5 were able to stop corticosteroid therapy).

What is the risk associated with Nucala - Mepolizumab?

The most common side effect of Nucala (which may affect more than 1 in 10 people) is headache. In addition, reactions at the injection site and back pain (back pain) are common, affecting up to 1 in 10 patients. For the full list of side effects and limitations with Nucala, see the package leaflet.

Why has Nucala - Mepolizumab been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nucala's benefits are greater than its risks and recommended that it be approved for use in the EU. The reduction of severe asthma attacks and the consequent need for hospital care was considered an important and predominant factor compared to the low risk of undesirable effects, since the safety profile of the medicine did not raise major concerns. Furthermore, a dose reduction of corticosteroids of 5 mg per day, although modest, was considered clinically relevant given the complications associated with long-term treatment with corticosteroids.

What measures are being taken to ensure the safe and effective use of Nucala - Mepolizumab?

A risk management plan has been developed to ensure that Nucala is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nucala, including the appropriate precautions to be followed by healthcare professionals and patients.