The Food and Drug Administration cleared 25 novel treatments in 2008, up from 19 the previous year, for the most since 2004. Approvals through November were listed on the FDA Web site. Ira Loss, an analyst in Washington, tallied the rest. The list excludes reformulated drugs and those that have been previously approved for other uses.

Among the new medicines were Nplate from Amgen Inc., the world’s largest biotechnology company, to treat a bleeding disorder afflicting 60,000 Americans. GlaxoSmithKline Plc and Ligand Pharmaceuticals Inc. were cleared to sell Promacta for the same condition. Regeneron Pharmaceuticals Inc., whose biggest shareholder is Sanofi-Aventis SA, put its first drug on the market, Arcalyst, for a group of inflammatory diseases diagnosed in about 500 people in the U.S.

“This is a more specialized list of drugs than I’ve seen in a while,” said Christopher-Paul Milne, associate director of the Tufts Center for the Study of Drug Development, in Boston, in a telephone interview.

Loss monitors the FDA for the consulting firm Washington Analysis.

Also on the list of treatments for rare disorders was Cinryze, owned by ViroPharma Inc. through the October acquisition of Lev Pharmaceuticals Inc. It was approved for hereditary angioedema, an inflammatory disease with about 10,000 sufferers in the U.S.

Diagnostic Agents

Four approvals were for injected products that help diagnostic equipment produce images, including General Electric Co.’s. AdreView for detecting rare tumors in adults and children. The FDA also cleared a sedative for patients undergoing diagnostic procedures using scopes. Two drugs were approved for constipation from surgery or painkillers.

“It’s a disappointing list,” said Raymond Woosley, president of the Critical Path Institute, a Tucson, Arizona-based organization formed in 2005 by the FDA and University of Arizona to find ways to streamline drug approvals. “We need more drugs and more drugs for serious, major diseases.”

Woosley, in a telephone interview, criticized the lack of new medicines for Alzheimer’s and Parkinson’s diseases. Three drugs were approved for cancers, including Genzyme Corp.’s Mozobil, which boosts the number of bone marrow stem cells that can be transplanted to blood-cancer patients. One depression drug and one AIDS drug were approved.

In 2004, the FDA approved 36 new medicines. That compares with a recent high of 37 in 1999.

‘Insufficient Resources’

Loss said in a note to investors that “insufficient resources at the agency” held back approvals in 2008 and the pace may pick up when the FDA has more staff and new leadership in the second half of this year. More than 800 newly hired reviewers will have finished training by then, he said.

“Some of the delays were caused by clinical issues, and those are acceptable,” he wrote.

The agency failed to decide whether to clear at least 15 products within the timetable established by Congress.

The FDA has faced pressure from members of Congress for stricter oversight of drug safety since Merck & Co. withdrew its painkiller Vioxx in 2004 because of increased heart risks, and since Glaxo’s diabetes drug Avandia was linked in 2007 to heart attacks.

None for Merck

Merck, which had no new drugs cleared this year and failed to win U.S. regulatory approval for its experimental cholesterol pill Cordaptive, says the FDA has changed its approval standards.

“They are being more conservative with their approach than in the past,” said Richard T. Clark, chief executive officer of the Whitehouse Station, New Jersey, company, at a Dec. 9 news conference.

The FDA disputes that, saying approval standards haven’t changed. Scientific advances in recent years have enabled the FDA to better understand and detect risks, according to the agency.

“In my 16 1/2 years at FDA, I have never received or issued an order to speed up or slow down,” said John Jenkins, head of the agency’s Office of New Drugs, at an industry conference in Washington last month. “We review each application on its merits and apply our best judgment with regard to the data, the science and the regulations.”

Fewer Applications

Steven Paul, executive vice president for science and development at Eli Lilly & Co., of Indianapolis, said in an interview that he doesn’t fault the agency for fewer approvals in recent years.

“Our industry’s challenges more reside with our ability to produce innovative medicines,” Paul said in an interview.

The FDA’s Web site lists 17 “new molecular entities,” or novel chemical treatments, approved through November of last year. Four more were approved in December, according to Loss.

In addition, the agency cleared four new treatments last year that use biotechnology, gene-based products derived from living organisms, Loss said. That compares with two in 2007.

Karen Riley, an FDA spokeswoman, said the agency hadn’t tallied the approvals for last year and couldn’t confirm the total. The approval figures don’t include expanded uses of existing medications, vaccines or products similar to those already on the market.

UCB Leads List

UCB SA, of Brussels, won approval of three products, more than any other company: Cimzia, for the bowel disorder Crohn’s disease; Vimpat for epilepsy; and Toviaz, a bladder-control drug marketed by Pfizer Inc., the world’s largest drugmaker. Cimzia is one of the four biotech drugs.

Johnson & Johnson of New Brunswick, New Jersey, won approval of Intelence for AIDS and tapentadol for pain. Glaxo, of London, won approval with Adolor Corp. for Entereg, to ease constipation after intestinal surgery, in addition to Promacta.

Wyeth of Madison, New Jersey, won approval for Pristiq for depression and, with partner Progenics Pharmaceticals Inc., Relistor for constipation caused by opium-like painkillers such as morphine.

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