Regulatory briefs: Sanofi's Fluzone; Roche' RoActemra; Takeda's Rienso

French pharma major Sanofi (Euronext: SAN) today (June 10) announced that the US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Fluzone Quadrivalent vaccine or use in children six months of age and older, adolescents, and adults. Fluzone Quadrivalent vaccine includes two A strains and two B strains for protection against influenza disease. The Fluzone Quadrivalent vaccine will be available to health care providers in the USA for the 2013-2014 influenza season in prefilled syringes and single-dose vials for intramuscular administration.

Swiss drug major Roche (ROG: SIX) has received European Medicines Agency approval for RoActemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis in patients aged >2 years who have not adequately responded to methotrexate. RoActemra can be used alone or in combination with MTX.

Takeda (TYO: 4502), Japan’s largest drugmaker, has submitted a type-2 variation to the EMA for Rienso (ferumoxytol) for iron deficiency anemia in adult patients with chronic kidney disease patients who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used.