FDA updates Arava label to include sterner liver safety warning
This article was originally published in Scrip
Executive Summary
The US FDA is updating the black box warning on Sanofi-Aventis's rheumatoid arthritis drug Arava (leflunomide) to highlight the risk of severe liver injury in patients taking the drug. Arava already has a black box warning noting that the drug cannot be used in pregnant women due to risk of causing fetal harm. It also has a bolded warning, added in 2003, about the risk of liver injury.
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.