Novartis has been boosted by new data on its hypertensive Rasilez/Tekturna which shows that the drug offers potential kidney protection in type 2 diabetic patients.

The data, which has been published in this week’s New England Journal of Medicine demonstrate that the first-in-class direct renin inhibitor Rasilez (aliskiren) shows potential kidney-protective benefit independent of its blood pressure lowering effects, said Novartis. The data comes from the 24-week AVOID study which involved 599 patients with type 2 diabetes, hypertension and kidney disease.

In the study, aliskiren was added to the treatment regimen of type 2 diabetics diagnosed with hypertension who were already receiving Merck & Co’s Cozaar (losartan) and had albuminuria levels greater than 200 mg/g. The data showed that Rasilez (150 mg increasing to 300 mg daily) reduced albuminuria (an indicator of kidney disease) by an additional 20% when added to the maximum dose of losartan (100 mg). Furthermore, a quarter of patients taking aliskiren added to losartan experienced albuminuria reductions greater than 50% compared to those patients taking Cozaar alone.

Two ‘infection-related incidents’ in MS drug trial
Meantime, Novartis noted that two patients taking its experimental multiple sclerosis drug FTY720 (fingolimod) in clinical trials have suffered “infection-related incidents”, one of which resulted in death. However late-stage trials of the compound will continue.

"Both cases involved confounding factors, including the use of very high doses of steroids in the first patient and the delayed use of antiviral therapy in the second patient," the Basel-based firm said. It added that fingolimod’s role in the cases was unclear but could not be excluded, since its mechanism of action leads to suppression of the immune system, which can increase the risk of infection.

Novartis hopes to submit the once-daily therapy for approval before the end of 2009.

Reclast indication expanded
Finally the firm noted that the US Food and Drug Administration has broadened the use of the osteoporosis drug Reclast/Aclasta (zoledronic acid) to include the prevention of new fractures in patients who have recently had a low-trauma hip fracture.

The expanded use of Reclast, which is given as a once-yearly 15-minute intravenous infusion, is based on data which demonstrated a 35% reduction in the risk of new clinical fractures in patients taking the drug.