Odanacatib regulatory update

Merck disclosed in its 4Q12 and 2012 earnings that it will delay to 2014 from 1H13 the expected submission of regulatory applications in the U.S., EU and Japan for odanacatib to treat osteoporosis. The pharma said the delay is a result of its decision to include in the submissions data from more than 8,000 women in a double-blind extension of a Phase III trial for the cathepsin K inhibitor. Merck said it received data from the Phase III trial but not the extension study. The pharma said it will not present the results or provide additional safety or efficacy information until the extension study is unblinded.

Last July, Merck said it would close early a Phase III trial of odanacatib after the study's DMC recommended stopping the trial early due to the "robust" efficacy in reducing fracture risk and a favorable benefit-risk profile of the compound. However, at the time the pharma said the DMC "noted that safety issues remain in certain selected areas" and recommended that the pharma continue the double-blind extension of the trial to monitor the issues (see BioCentury, July 16, 2012). ...