Vectura Group PLC (LON:VEC) has drawn attention to a recommendation relating to the use of one of the company’s asthma treatment formulations in Europe.
In a statement, the company noted that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Novartis's Enerzair Breezhaler (QVM149).
Enerzair Breezhaler, which uses a formulation devised and licensed by Vectura, is a maintenance treatment for uncontrolled asthma in adult patients. Uncontrolled patients are those whose asthma is not adequately controlled with a maintenance combination of a long-acting beta2 agonist (LABA) and a high dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.
A final decision from the European Commission regarding the grant of a marketing authorisation is expected to be received roughly two months after a CHMP opinion. Upon European regulatory approval, Vectura will be eligible to receive a US$5.0 million milestone and thereafter a low-single-digit royalty on net sales.