ZURICH, June 16 (Reuters) - Novartis AG NOVN.VX has withdrawn an marketing application for its Aflunov pandemic influenza vaccine in Europe, the European Medicines Agency (EMEA) said on Monday.
Aflunov had been expected to be used for pre-pandemic immunisation against the H5N1 subtype of the influenza A virus, Europe’s drugs watchdog said.
The drug had been under review by EMEA’s Committee for Medicinal Products for Human Use (CHMP), which had requested additional clinical data.
Swiss drugmaker Novartis told the medicines agency it could not supply the additional data within the required timeframe.
While H5N1 remains mainly a virus of birds, scientists say it is the most likely source of the next global flu pandemic in humans, since it may soon mutate into a form that is transmitted easily from person to person.
Recommendations for marketing approval by the CHMP are normally endorsed by the European Commission within a couple of months. (Reporting by Sam Cage; Editing by David Holmes)