Drug Approvals Slipped in 2010: Report

The Food and Drug Administration (FDA) approved about 21 drugs in 2010, The Wall Street Journal reported Friday, a relatively modest figure that shows the pharmaceutical industry has not yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

The final approval figures, as well as the number of applications received by the agency in 2010, will not be available until next month. The approval figures do not include dozens of approvals granted for new formulations or new uses of existing drugs.

Although the 2010 figures are a bit lower than previous years, FDA spokeswoman Sandy Walsh said there is "no systemic change in how the FDA is approaching drug approvals."

The figures include several major biologic drugs, which are created from living cells and represent a growing portion of the pharmaceutical market.

However, 2010 may be more notable for drugs that were not approved, as well as for drugs the agency restricted or pulled off the market.

The FDA closed the books on one of the highest profile drug-safety matters in recent years by sharply curtailing the use of GlaxoSmithKline's diabetes drug Avandia in September after it was linked to increased risks of heart attacks.

The agency said this week it needed more time to review MannKind Corp.'s inhaled-insulin product to treat diabetes. It also said it needed until next March to review Benlysta, a highly anticipated lupus drug from Human Genome Sciences Inc. and GlaxoSmithKline.

Read more: http://online.wsj.com/article/SB10001424052748704543004576052170335871018.html