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).
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.
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