AstraZeneca’s rheumatoid arthritis pill fostamatinib shows mixed results in trial
08 Apr 2013
Fostamatinib, an experimental rheumatoid arthritis pill, developed by AstraZeneca has been only able to meet one goal of two, in a late-stage clinical trial. The result leaves the future of one of the group's few advanced pipeline products uncertain.
Fostamatinib, has been touted as a potential competitor to injectable drugs like AbbVie's Humira, as also a new pill from Pfizer called Xeljanz in a market estimated at over $20 billion. But, in view of disappointing results from earlier tests, the latest development might not have dashed many investor hopes.
The latest findings would hardly do anything to restore investor confidence, especially with increased blood pressure and diarrhea seen among patients taking the AstraZeneca product.
Results of another AstraZeneca-funded study in December found the results of fostamatinib use fell short of Humira in controlling arthritis symptoms.
In the latest trial, the company's new drug achieved a statistically significant improvement at 24 weeks, as against a placebo, in a test assessing signs and symptoms of the disease - the so-called ACR20 response rate.
However, it did not show an improvement in an X-ray test measuring the progression of joint damage, results from the OSKIRA-1 Phase III study released by the company on Friday.
The drug's side effects were similar to those experienced in earlier studies, including common cold, hypertension, diarrhea, nausea, and headache.
Briggs Morrison, executive vice president of global medicines development, said in a statement, the trial showed the drug ''has an effect on the signs and symptoms of rheumatoid arthritis.'' The statement added, ''We will await the results of the remaining Phase III studies, Oskira-2 and Oskira-3, to further evaluate and characterise the profile of fostamatinib as a potential treatment for rheumatoid arthritis.''
According to analysts, the results might increase concerns that fostamatinib lacked commercial potential. The company, the second-largest drugmaker in the UK, has been looking to new products to ease a sales slump caused by competition from generic medicines.
According to AstraZeneca, results from Oskira-2 and Oskira-3 would be due later in the second quarter.
AstraZeneca was down as much as 0.3 per cent to 3,279 pence and was trading down 0.2 per cent in morning London trade. Investments in the stock had returned 25 per cent in the past year, including reinvested dividends, as against 30 per cent for the Bloomberg Europe Pharmaceutical Index.
San Francisco, California-based Rigel Pharmaceuticals Inc is AstraZeneca's partner on the drug.
