US FDA approves Merck KGaA's Rebif Rebidose

German drug major Merck KGaA’s (MRK: DE) US subsidiary EMD Serono and pharma behemoth Pfizer (NYSE: PFE) yesterday announced that the US Food and Drug Administration approved Rebif Rebidose (interferon beta-1a), a single-use auto-injector for the self-administration of Rebif, a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS).

Pfizer gained co-promotion rights for Rebif in the USA in 2002, under a deal which included a $200 million upfront payment to Merck. The drug generated sales of 1.69 billion euros ($2.23 billion) in 2011, some 46% of which came from North America.

“We are pleased to announce the FDA has approved Rebif Rebidose which provides people living with relapsing MS another option to meet their injection needs,” said James Hoyes, president of EMD Serono, adding: “The introduction of Rebif Rebidose underscores our commitment to the MS community and to our investment in the development of delivery devices to assist with ease of use and support those living with MS.”