US FDA rejects AstraZeneca's Axanum and expanded Nexium indication
This article was originally published in Scrip
Executive Summary
The US FDA has issued two complete response letters to AstraZeneca, denying an approval for Axanum (aspirin plus esomeprazole magnesium) and an expanded indication for Nexium (esomeprazole magnesium). Axanum had been filed for low-dose aspirin-associated gastric and/or duodenal ulcers in patients at risk, whereas Nexium had been filed for low-dose aspirin-associated peptic ulcers.
You may also be interested in...
Pfizer's tanezumab hits a nerve (growth factor)
Experimental drugs rarely face setbacks because they are too effective, but Pfizer's novel nerve growth factor antagonist tanezumab might number among the unlucky few. Phase II data presented this week in the NEJM show that the monoclonal antibody relieved osteoarthritic pain, but an accompanying editorial proposed that in doing so the analgesic enables physical activity that can lead to excessive wear and tear on fragile joints.
AstraZeneca moves syk kinase inhibitor into Phase III trials
AstraZeneca has enrolled the first patient in the pivotal programme for the first-in-class Syk kinase inhibitor fostamatinib (previously known as R778). Fostamatinib, which it licensed from Rigel Pharmaceuticals, is being evaluated as a treatment for rheumatoid arthritis (RA) in patients with an inadequate response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX).
Michael J. Fox foundation to spend $40 million on search for Parkinson's biomarkers
The Michael J. Fox foundation has launched a $40 million, 5-year initiative to identify biomarkers of Parkinson's disease progression. The scheme, called the Parkinson's Progression Markers Initiative (PPMI), will be carried out at 18 sites in the US and the EU, and will track 400 patients with newly diagnosed disease as well as 200 who do not have the disease.