EMA committee recommends approval of two Novartis products

The European Medicines Agency's Committee for the Medicinal Products for Human Use (CHMP) has given two of Novartis' products positive recommendations for approval.

The first is Novartis' Ultibro Breezhaler as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was developed under the name of QVA149, which is an investigational fixed dose combination of two bronchodilators, indacaterol, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium, a long-acting muscarinic antagonist (LAMA).

"The CHMP's positive opinion supports a major breakthrough in the treatment of COPD, where many patients do not have adequate treatment options. QVA149 has shown significant improvements compared with some of the most commonly used treatment options for COPD, which is projected to be the third leading cause of death by 2020."

David Epstein, Division Head, Novartis Pharmaceuticals.

The second product that has received recommendation for approval is Novartis' Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. SJIA is a rare and disabling form of childhood arthritis with limited treatment options.

"If approved, Ilaris would provide a new treatment option for patients whose choice of therapy has, to date, been very limited. This positive opinion by the CHMP is an important step towards the approval of Ilaris for SJIA in the EU."

Timothy Wright, MD, Global Head of Development, Novartis Pharmaceuticals.

The CHMP has recommended Ilaris for the treatment of active SJIA in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. CHMP stated that Ilaris can be given as monotherapy or in combination with methotrexate.

The European Commission generally follows the recommendations of the CHMP and usually shares its final decision within three months.