(Reuters) - British drugmaker Vectura said its asthma inhaler Flutiform had made favourable regulatory progress in Europe, and it can now apply for approvals through its partner.
Vectura said its partner Mundipharma confirmed a “successful outcome” for the inhaler, when first assessed by the UK medicines and healthcare products regulatory agency — which covers 18 countries across Europe.
“This positive DCP outcome is an important step in the regulatory process and Mundipharma can now begin to apply for national approvals and reimbursement in the European countries covered by this procedure”, Chief Executive Officer James Ward-Lilley said in a statement on Wednesday.
Last month Vectura’s shares tumbled after it reported a doubling of first-half losses and warned full-year revenues would be hit by customers running down stocks of the asthma inhaler.
Reporting by Justin George Varghese in Bengaluru; editing by Alexander Smith