In June 2014, AstraZeneca (one of the UK’s biggest pharmaceutical companies) and Amgen, a U. S. based biotech, announced results of the Phase II clinical trials of Brodalumab, a new drug treatment for psoriatic arthritis.
The study, published in The New England Journal of Medicine (NEJM), of 168 patients with psoriatic arthritis showed that treatment with brodalumab significantly improved signs and clinical symptoms associated with the disease, including tender and swollen joints, at 12 weeks as measured by a 20 per cent improvement in the American College of Rheumatology response criteria (ACR20). The study also showed that many patients continued to improve, and that the improvements were sustained, through the first 52 weeks of the study reported in NEJM.
Following these results, Amgen and AstraZeneca initiated two Phase III studies of brodalumab. In November 2014, the companies reported positive phase III results on brodalumab in moderate-to-severe psoriasis patients and were working on regulatory filings in the U.S. and EU. However, in the last few days (22 May) Amgen has announced the termination of its co-development agreement with AstraZeneca regarding brodalumab. Amgen cited the suicidal thoughts and behaviour observed in patients taking the medicine as a major contributory factor in its decision. Amgen believes that this finding would likely necessitate restrictive labelling thereby reducing the drugs market potential.
During our preparation process for regulatory submissions, we came to believe that labelling requirements likely would limit the appropriate patient population for brodalumab,
said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
Back in November Dr Harper noted:
Results from AMAGINE-2 underscore that treatment with brodalumab could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease, and the great majority achieve at least a 75 per cent improvement in their disease.
Although the psoriasis medication market is extremely crowded given the presence of products like Stelara, Enbrel, Otezla and Cosentyx, in the phase III trials brodalumab out-performed Johnson & Johnson’s market leading Stelara in direct study.
AstraZeneca has not yet decided how it intends to proceed or whether to continue regulatory filing to bring brodalumab to market.
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