Biogen Idec and Genentech were lifted yesterday by the news that their non-Hodgkin’s lymphoma drug Rituxan (rituximab) will be fast-tracked by the US Food and Drug Administration as a treatment for rheumatoid arthritis.
The two companies have filed for approval of Rituxan as a second-line biologic treatment for RA in patients who do not respond with anti-tumour necrosis factor alpha drugs, such as Schering-Plough’s Remicade (infliximab), Amgen’s Enbrel (etanercept) and Abbott Laboratories’ Humira (adalimumab). Approximately a third of patients who take anti-TNF drugs for RA do not respond to the treatment.
The news means that the companies should get a verdict on their application by the end of February. Already a blockbuster, if approved for RA Rituxan could add another $1 billion dollars in peak sales. In Europe, Rituxan is sold as MabThera by Switzerland’s Roche, which filed for approval in RA earlier this year [[06/09/05g]].
The overall market for RA treatments is tipped to double in size from $5.5 billion at present to $10.5 billion in 2008.
The RA fast-track follows on from an announcement last week that Rituxan received priority review as a first-line treatment for NHL, which would also expand the population of patients eligible for treatment with the drug [[26/10/05e]].
Expanded use of Rituxan would be a real boost for Biogen Idec, which has been struggling to recover from the voluntary withdrawal of its multiple sclerosis drug, Tysabri (natalizumab), on safety concerns [[01/03/05a]]. The company now hopes to reintroduce Tysabri and has filed for approval in the USA and Europe [[17/10/05b]].