Recent news of fostamatinib’s latest failure to meet clinical endpoints marks yet another blow to an already weakened rheumatoid arthritis (RA) therapeutics pipeline, and may drive manufacturers to investigate fresh approaches to drug development, says an analyst with research and consulting firm GlobalData.
This latest disappointment marks the official demise of AstraZeneca (AZ) and Rigel Pharmaceuticals’ (Rigel) troubled Phase III program for fostamatinib (entitled OSKIRA), and comes not long after Eli Lilly’s shelving of its RA candidate, tabalumab, in February.
“These recent events clearly show that the path to regulatory approval in RA remains a challenging one for both novel small molecules and biologics,” says Dina Rufo, immunology analyst with GlobalData.
“Considering these setbacks in the RA pipeline, we believe companies with RA therapies in early development are likely to be watching closely, and may need to reconsider their own clinical development programs in hope that they can bring their drugs to the market.”
With the latest competitors out of the picture, Pfizer’s approval of Xeljanz (tofacitinib) in the US (November 2012) and Japan (March 2013) appears even more significant. However, Pfizer’s product has not been without its own share of problems:
“Xeljanz has faced other obstacles,” states Rufo, “including a somewhat surprising negative ruling for its application for RA by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which Pfizer is likely to fight against over the coming months.
“As such, we believe that the CHMP’s decision will have a negative impact on Xeljanz’s development in other autoimmune indications, such as psoriasis and ulcerative colitis, with potentially limited early uptake,” adds GlobalData’s analyst.