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Lilly Forteo "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly's osteoporosis agent Forteo is "approvable" Oct. 2 for use in men and postmenopausal women. Approval of the recombinant parathyroid hormone, expected "between now and the end of 2002," is waiting on "labeling negotiations, agreement regarding measures assuring appropriate use of the product and successful completion" of manufacturing inspections, Lilly CEO Sidney Taurel said Oct. 3. Lilly said that labeling and use discussions, not inspections, are the central issues holding up approval. Use discussions likely relate to concerns expressed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in July. The committee was split on whether the drug should be used in men and recommended restricting use in postmenopausal women to high-risk patients or second-line treatment. Inspections need to be done at Lilly plants in France and Indianapolis. The France inspection may be complicated by reduced FDA travel following the events of Sept. 11. FDA lifted its international travel ban on Oct. 1 and is allowing "mission critical" trips on a case-by-case basis
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