FDA Approves Rituximab (Rituxan) for Rare Disorders

The U.S. Food and Drug Administration approved Rituxan, in combination with certain steroids, to treat patients with Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA).

Rituxan is already approved to treat rheumatoid arthritis, non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

It is an antibody that works by binding itself to a specific protein found on the surface of malignant and normal B-cell lymphocytes, enlisting the body's own immune system to kill marked cells.

source:medscape

FDA Approves PED Device to Treat Brain Aneurysms

A new device for treating brain aneurysms that spares the need for open surgery has been approved by the US Food and Drug Administration (FDA).

According to Christy Foreman of the Office of Device Evaluation, Center for Devices and Radiological Health, the Pipelineembolization device (PED) "offers neurointerventional surgeons an alternative to open surgery or placement of materials such as coils or a liquid embolic when treating carotid artery brain aneurysms."

The PED, manufactured by ev3, is a flexible mesh tube made of nickel-cobalt chromium alloy and platinum. The device can block giant and wide-necked aneurysms in the carotid artery that supplies blood to the brain. Furthermore, the PED reduces the chance that the aneurysm will rupture.

The PED is contraindicated in patients with an active infection and patients unable to take antiplatelet therapy, such as aspirin. Patients should receive adequate antiplatelet therapy before implantation of the device. The PED should not be used to treat a previously stented aneurysm.

source:medscape

Biomarker Sensitive Predictor of Alzheimer's Progression

Temporal horn volume expansion is a sensitive biomarker of Alzheimer's disease (AD) progression over time, accurately discriminating between patients with an underlying disease process from normal elderly controls (NECs).

Presented here at the Alzheimer's Disease International 26th International Conference, research by Amanda Khan, MSc, University of Western Ontario, London, Canada, showed only patients with an underlying disease process, including mild cognitive impairment (MCI) and AD, had evidence of significant enlargement in the temporal horn region of the ventricular system during a 2-year time span compared with NECs.

Changes in both total ventricular and total horn volume were adjusted by age, sex, education, the presence of at least 1 ApoE-4 allele, and the Alzheimer's Disease Assessment Scale–cognitive subscale score.

Dr. Korczyn noted that changes in temporal horn volume would also allow researchers to objectively monitor response to treatment, which is not currently possible using standardized cognitive tests.

"If we can identify changes early, before patients have clinical manifestations of AD, this is the window of opportunity where we may be able to slow down these changes with treatment."

source:medscape