Sanofi-Aventis says it has submitted a supplemental application with US regulators to get a licence for its influenza A (H1N1) monovalent vaccine.

The French drugmaker’s Sanofi Pasteur unit noted that the filing, responding to recent recommendations by the US Food and Drug Administration, will use “the same regulatory process by which the agency approves new viral strains contained in annual seasonal influenza vaccines". The company says that its supplemental application “specifies the evaluation of a non-adjuvanted vaccine”, adding that although not required, it will provide immunogenicity and safety data for the monovalent vaccine through US studies which began on August 6.

The trials, Sanofi said, which will involve approximately 2,000 people, will also examine the potential benefits of adding an adjuvant, which boosts the body’s immune response, to the pandemic vaccine.

Wayne Pisano, chief executive of Sanofi Pasteur, noted that filing the application “is consistent with our commitment to work collaboratively with public health officials” in producing a swine flu therapy. He added that it is “essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine.”

Meantime, rumours that Sanofi may be looking at buying the USA’s Allergan have resurfaced. The news service Pharmawire, reported on, quoted an unnamed source as saying that Allergan, which specialises in ophthalmic, aesthetic and skin products, is at the top of Sanofi chief executive Chris Viehbacher’s M&A wish list.