FDA approvals down, early stage pipelines filling up

While the number of new FDA approvals by big pharma has declined this decade, the rate of compounds entering testing is on the upswing, notes a new report. The FDA approved only 17 new drugs last year and 20 the previous year. The ebb marks a fresh low in the number of new drug approvals in recent years and a marked contrast to the 53 approval high of a decade ago. The low approval figures come as no surprise, says Ken Kaitin, director of the Tufts Center for the Study of Drug Development, which drafted the report. They’re the result of a lack of products reaching phase III. “But these situations tend to be cyclical,” he told MM&M. “Now we’re seeing a rebuilding of the early clinical pipeline, which we’ll see the effects of in the next five to eight years.” Whether the FDA is just getting tougher in the post-Vioxx era is an open question. Kaitin says the report does not go into the number of new drug applications for new molecular entities the FDA received and turned down in recent years. But the restocking of pipelines is cause for optimism. According to Tufts’ “Outlook 2007,” the rate of new agents increased 52% from 1998-02 to 2003-05, following a decline of 21% during the 1990s. That’s partly due to a greater number of partnerships between small/mid-tier pharma and big pharma. Of the 2,000 drug candidates in early clinical trials, one in five were discovered by small biotech companies. One of the major problems for industry is clinical failures early in development. Nothing illustrates that better than torcetrapib, the compound Pfizer spent $800 million developing only to cancel in phase III. “The key for industry is to fail faster,” Kaitin said. There has been progress toward reaching that goal, including a greater sharing among companies of pre-competitive research and safety biomarkers—he cited Pfizer and GlaxoSmithKline as examples—to reduce late-stage development failures and contain rising costs. To bring a medicine to market costs upward of $1.5 billion per drug and takes as long as 15 years.