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For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

So far, the approval trends for new molecular entities and novel biologics in the first half of 2008 suggest that this year’s final tally may look very similar to last year’s record-low approval total.

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Centocor’s ustekinumab delayed

FDA pushes Centocor's ustekinumab PDUFA date to December, granting the agency more time to review BLA amendments, the firm announces Aug. 8. Ustekinumab was unanimously recommended by an FDA advisory committee in June for approval for moderate to severe psoriasis, but the panel asked the J&J unit for long-term studies to evaluate cancer risk. The drug, which is aiming for a dosing advantage with a four injections per year regimen, was originally slated for an agency decision in September (1Pharmaceutical Approvals Monthly July 2008, p. 3). According to Centocor, FDA is not seeking additional clinical trials for ustekinumab

2008 NME approvals reach ten, with seven in the first half and three so far in the second

FDA approved seven new molecular entities in the first half of 2008, equal to the first-half total for 2007. Pharmaceutical Approvals Monthly erred in reporting six first-half approvals; Sirion's Durezol (difluprednate), approved June 23, was absent (1Pharmaceutical Approvals Monthly July 2008, p. 3). Durezol is indicated for treatment of inflammation and pain associated with ocular surgery. FDA needs to clear ten NMEs in the second half of 2008 if it is to exceed 2007's record low total of 16 NMEs. The NME approval tally stands at ten as of the last week of August. Bayer's imaging agent Eovist (gadoxetate) was approved July 3, The Medicines Company's I.V. antihypertensive Cleviprex (clevidipine) cleared the agency on Aug. 1, and Prestwick's orphan Xenazine (tetraberazine) was approved Aug. 15 for Huntington's chorea

FDA First Cycle Approval Rate Is Silver Lining In Cloud Of Dismal NME Count

Three-quarters of the new molecular entities cleared by FDA in 2007 were approved on the first review cycle, a high for this decade and a positive note to counterbalance the record low number of NMEs approved.

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