Reslizumab for Severe Asthma Gets Nod From EU Regulators


June 24, 2016

European Union (EU) regulators yesterday recommended approval of reslizumab (Cinqaero, Teva Pharmaceuticals) as an add-on maintenance drug for adults with severe eosinophilic asthma that is not adequately controlled by high-dose inhaled corticosteroids.

The recommendation comes from the Committee for Medicinal Products for Human Use, part of the European Medicines Agency (EMA).

Reslizumab, a monoclonal antibody, lowers blood levels of eosinophils, a type of white blood cell that can cause airway inflammation. Patients receive the drug by infusion.

The US Food and Drug Administration approved reslizumab, marketed here as Cinqair , in March.

The most common adverse events that emerged in the clinical trials for the asthma drug are increased blood creatine phosphokinase, muscle pain, and anaphylaxis, according to an EMA news release. EMA noted that "an imbalance of malignant neoplasms" was observed between the placebo and treatment arms of the drug's clinical trials. Earlier this year, Teva Pharmaceuticals disclosed that 0.6% of patients receiving 3 mg/kg reslizumab had at least one malignant neoplasm reported compared with 0.3% of patients in the placebo group.

The EMA recommendation to approve reslizumab now goes to the European Commission, the EU's executive branch, for a final decision.

New Version of Salmeterol/Fluticasone Advanced

The European Commission will take up another EMA recommendation from June 23 to approve a combination of salmeterol xinafoate and fluticasone propionate (Aerivio Spiromax, Teva Pharmaceuticals) for severe asthma and chronic obstructive pulmonary disease in adults. Salmeterol xinafoate is a selective long-acting inhaled beta-adrenoceptor agonist, while fluticasone propionate is an inhaled glucocorticoid with anti-inflammatory activity in the lungs.

Clinicians should not use the combination drug to initiate treatment of severe asthma "unless the requirement for such a high dose of the corticosteroid together with a long acting beta 2 agonist has been previously established," EMA stated.

The combination of the two drugs has long been available in Europe in the form of Seretide Diskus. Teva Pharmaceuticals' version will be a single, high-strength, 50-mcg/500-mcg inhalation powder. The company will market it in most European countries as Aerivio Spiromax and in a few others as Airexar Spiromax, a Teva Pharmaceuticals spokesperson told Medscape Medical News.


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