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Biotech / Medical : NPSP NPS Pharmaceutical -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (190)	3/12/2004 2:54:45 PM
From: tuck	Read Replies (1) \| Respond to of 363

>>Human parathyroid hormone and rat osteosarcoma 28 February 2002 Eric G Colman, Medical Officer - U.S. FDA 20857, Gemma Kuijpers, Bruce Schneider, Bruce Stadel Human parathyroid hormone and rat osteosarcoma Editor — As members of the U.S. Food and Drug Administration’s (FDA) Division of Metabolic and Endocrine Drug Products responsible for the review of Eli Lilly’s teriparatide (PTH1-34) application, we would like to respond to Dr. Jonathan Reeve’s 2/23/2002 editorial, Recombinant human parathyroid hormone1. Although the FDA’s Advisory Committee concluded that the company provided sufficient evidence to support the efficacy of teriparatide in the treatment of postmenopausal osteoporosis and idiopathic and hypogonadal osteoporosis in men, the committee did voice concern about osteosarcomas that developed in rats treated with the drug. In contrast to Dr. Reeve’s assertion that rats received “huge doses” of teriparatide, some animals developed osteosarcomas when treated with doses that were approximately 3 times the expected daily human exposure – a relatively small safety margin by conventional standards of drug development. While several factors limit the ability to extrapolate the rat findings to humans, we did not dismiss the preclinical data as clinically irrelevant and believe that they should be factored into the drug’s benefit-to-risk profile. A complete discussion of teriparatide’s efficacy and safety can be found in the transcript of the July 2001 FDA Advisory Committee Meeting2: fda.gov The views expressed above are those of the authors and do not necessarily reflect the official position of the U.S. FDA Competing interests: None 1. Reeve J. Recombinant human parathyroid hormone. BMJ 2002; 324: 435 -436.<< bmj.bmjjournals.com Worth noting that only one animal developed a problem -- with uncertain origin -- at a dose four times the proposed dose in humans. Message 19792097 Cheers, Tuck