FDA approval of Utibron/Seebri Neohalers triggers $22.5 million payment to Vectura by Novartis
The US Food and Drug Administration has approved the dual combination bronchodilator Utibron Neohaler (indicaterol/glycopyrrolate) and the standalone monotherapy Seebri Neohaler (glycopyrrolate) from Vectura (LSE: VEC) and Novartis (NOVN: VX).
The products have been approved for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This approval triggers a $22.5 million milestone payment from Novartis to Vectura, a UK-based developer of inhaled therapies.
Approval was based on data showing that Utibron Neohaler demonstrated superior and sustained improvements in lung function compared to its individual bronchodliator components as well as placebo. Utibron Neohaler also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo.
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