Zelnorm Chronic Constipation Claim Could Increase Target Market By 50%
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis’ upcoming sNDA for a Zelnorm chronic constipation indication could increase the potential patient population for the drug by roughly 50%.
You may also be interested in...
Sucampo lubiprostone NDA submitted
Sucampo expects a standard review for its chronic idiopathic constipation agent lubiprostone, putting the user fee deadline at Jan. 31, 2006. The firm believes the oral chloride channel activator "may offer a more targeted approach to managing the symptoms of constipation." Novartis' 5-HT4 antagonist Zelnorm (tegaserod) gained a chronic constipation indication in August 2004. Sucampo is also studying lubiprostone for post-operative ileus and constipation-predominant irritable bowel syndrome (1Pharmaceutical Approvals Monthly November 2003, p. 12)...
Zelnorm Surgery Incidence Halved Via Novartis/FDA Adjudication
Re-analysis of surgical cases in clinical trials for Novartis’ constipation-predominant irritable bowel syndrome therapy Zelnorm reduced the incidence of the events by more than half, FDA review documents indicate.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011