Targeted cancer therapies boost drug approval rate

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WASHINGTON -- U.S. drug approvals in 2012 reached their highest level in 15 years, led by 11 new cancer therapies, including Ariad Pharmaceuticals's Iclusig and Pfizer's Bosulif, both aimed at forms of leukemia.

The Food and Drug Administration cleared 39 novel medicines in 2012, nine more than a year earlier, agency data show. Among the non-cancer products were Arena Pharmaceuticals's Belviq, the first new prescription weight-loss pill in 13 years, and Johnson & Johnson's Sirturo, aimed at patients with tuberculosis who are resistant to multiple-drug therapies.

Approvals of innovative drugs have averaged about 23 a year over a decade. The FDA tightened its safety standards after the high-profile 2004 failure of Merck & Co.'s painkiller Vioxx and other drugs. Since then, companies have included more safety studies as part of their development strategies, and shifted their focus to specialty drugs with higher chances of approval because they target patients on whom they're most likely to be effective.

"The sheer number, I think, supports the correctness in some of the strategy shift of the pharmaceutical companies over the last number of years," Rick Edmunds, a senior partner at Booz & Co. who leads the consulting firm's global health care practice in Washington, said in a phone interview. The rate "implies pharma growth potential to 2015 and beyond."

The FDA signed off on 53 novel drugs in 1996, the most since it began sharing aggregate data, and 39 in 1997. There were 36 approvals in 2004, the year the agency began counting therapeutic biologic medicines, made from living organisms.

Oncology drugs were high on the FDA's approval list last year and will likely remain a good area for investors in 2013, as the FDA division that reviews those treatments seems more willing to clear new medicines, Ira Loss, an analyst at Washington Analysis LLC, said in a phone interview.

Diabetes drugs still face hurdles, Mr. Loss said. AstraZeneca and Bristol-Myers Squibb as well as Johnson & Johnson are attempting to bring diabetes treatments to market that excretes excess blood sugar into patients' urine. London-based AstraZeneca and Bristol-Myers have been working for a year to answer FDA questions on dapagliflozin. The FDA is scheduled to decide on J&J's canagliflozin by the end of March.

The FDA also is weighing the risks and benefits of Novo Nordisk's once-a-day insulin Tresiba after advisers to the agency determined in November that the Bagsvaerd, Denmark-based company provided sufficient efficacy and safety data to support marketing of the drug. They also said Novo should conduct a cardiovascular safety trial.



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