Advanced Life Sciences' Cethromycin For CAP Cleared For FDA Submission
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Firm plans third quarter NDA for mild-to-moderate community-acquired pneumonia indication. ALS CEO says the filing milestone will help with its search for a partner
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FDA Panel Offers Specifics For Revised CAP Trial Guidance, No Big Changes
Advisory committee proposes a 10% non-inferiority margin for community-acquired pneumonia drugs. The Anti- Infective Drugs panel agreed that it is possible to establish a treatment effect for comparator agents based on incomplete data from original placebocontrolled CAP trials of the early 1900s. However, the group was divided over whether there is a basis for evaluating endpoints other than mortality. There was consensus that placebo-controlled trials are inappropriate for any severity of CAP
R&D In Brief
AtheroGenics AGI-1067 dose range restricted in Phase III due to liver concerns: The high-dose 300 mg arm of AtheroGenics' Phase III ANDES trial will be discontinued due to liver toxicity concerns, the company announces Nov. 9. Additional analysis of an earlier Phase III study, ARISE, found rare adverse effects on the liver with a 300 mg dose of the oral anti-inflammatory antioxidant AGI-1067. ANDES was designed to elucidate subgroup effects seen in diabetic patients enrolled in ARISE, a pivotal atherosclerosis trial that failed to meet its primary cardiovascular event endpoint. AtheroGenics and then-partner AstraZeneca had hoped ARISE would support multiple claims for AGI-1067 in subgroups. After the stumble with ARISE, AtheroGenics shifted its focus for AGI-1067 from atherosclerosis to glycemic control in type 2 diabetes. ANDES started enrolling diabetes patients in August as a dose-ranging trial to confirm the ARISE diabetes findings. The trial will continue with the two lower-dose arms (75 and 150 mg); an interim analysis is planned for the second quarter of 2008...
IFRA Hosts Capitol Hill Scent Experience In Timeout From Policy Concerns
The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.