Serono submits Rebif sBLA to US FDA

Swiss biotechnology firm Serono has submitted a supplemental Biologics Licence Application to the US Food and Drug Administration, as well as a variation to the current Marketing Authorization to the European Medicines Agency (EMEA) for a new formulation of Rebif (interferon beta-1a), its treatment for multiple sclerosis.

According to the Geneva-headquartered group, data from a Phase III clinical trial in patients with relapsing forms of MS show that the new formulation of Rebif results in a substantial improvement in overall tolerability, as measured by prespecified parameters including injection site reactions, which are an important factor for patients when choosing an MS therapy.

The trial data indicated that an added benefit with the new formualtion is that it reduces the incidence of antibody formation and Serono says it expects to present all the Phase III data at a major medical conference in the second half of the year.