FDA Approves Boxed Warning On Cancer Risk For Elidel And Protopic
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency finalized the addition of the boxed warnings and revised indications for the eczema therapies' labels one year after a similar recommendation by an FDA advisory committee.
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The addition of boxed warnings regarding cancer risk for Novartis' and Astellas' eczema treatments comes almost one year after FDA's Pediatric Advisory Committee recommended the labeling changes for topical calcineurin inhibitors. The committee recommended a "black box" warning at its Feb. 15, 2005 meeting to communicate potential cancer risks associated with calcineurin inhibitors (1 (Also see ""Black Box" For Protopic, Elidel Is "Blunt" But Necessary Instrument, Advisory Cmte. Says" - Pink Sheet, 16 Feb, 2005.)). FDA announced approval of updated labeling for Novartis' Elidel (pimecrolimus) and Astellas' Protopic (tacrolimus) Jan. 19. The boxed warnings, which appear in the Warnings section and not at the top of the label, state: "Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established." "Although a causal relationship has not been established, rare cases of malignancy (e.g. skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors," it adds. The warnings emphasize that continuous, long-term use should be avoided and that the ointments are not indicated for use by children under two years of age. FDA also announced labeling revisions to clarify that the drugs are recommended for use as second-line therapy. Updated labeling for Protopic states that the treatment is "indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable." Previous versions of labeling for Protopic did not use the phrase "second-line therapy." Elidel labeling has similar language changes to its Indications section. Although FDA took approximately one year to finalize labeling changes, Office of Drug Evaluation III Deputy Director Julie Beitz asserted that the agency has "been working very diligently for these past several months....What we've done is convened an internal team of experts. We included dermatologists, pediatricians, drug safety evaluators, epidemiologists, pharmacologists...to reassess all the data that we had." "We really wanted to be sure that we understood what the data were telling us and were able to communicate it in an accurate way," Beitz said. Novartis and Astellas are conducting long-term safety studies that the firms hope will exonerate their eczema products from being identified as cancer-causing agents (see 2 (Also see "Novartis, Astellas Intend To Disprove Eczema Treatments’ Cancer Risk" - Pink Sheet, 19 Jan, 2006.) ). "We certainly acknowledge that there have been differences in opinion about whether there is or is not a cancer risk. We also acknowledge that there are certainly different approaches that one could take to communicate what it is that we do know," Beitz said. -Christopher Hollis |