News briefs: Italy lifts hold on Novartis vaccines; files for QVA149 in Japan; Mylan patent settlement

The Italian Medicines Agency (AIFA) said last Friday that the temporary halt on the use of Swiss drug major Novartis’ (NOVN: VX) Agrippal and Fluad flu vaccines in Italy, imposed last month (The Pharma Letter October 29), has been lifted. This follows additional information provided by the company and AIFA's independent assessment, which reaffirm the vaccines' safety and efficacy. For the 2012-2013 influenza season, more than one million doses have been administered with no unexpected adverse events reported to date.

Distribution already resumed for Canada and Switzerland on October 31, 2012, as well as Singapore on November 2, 2012. Within the European Union, Italy is the regulatory reference country for Agrippal and Fluad. Novartis will continue to work with other countries to lift remaining precautionary measures and resume supply as soon as possible.

Also, the firm’s Japanese unit, Novartis Pharma KK, has submitted an application for the registration of QVA149, an investigational fixed dose combination of two long-acting inhaled bronchodilators (indacaterol maleate and glycopyrronium bromide), as a once-daily treatment for chronic obstructive pulmonary disease (COPD) in Japan. The application for QVA149 was filed to the European Medicines Agency in October 2012 and the US application is planned for 2014.