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HEALTH INDUSTRY

DECEMBER 31, 2010

Drug Approvals Slipped in 2010
Some Potential Blockbusters Suffered Delays Amid FDA's Tougher Safety Stance
By JENNIFER CORBETT DOOREN

WASHINGTON—The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't 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, won't be available until next month. The approval figures don't 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's "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. View Full Image Amgen Inc. won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women. Roche Holding AG's biotechnology unit, Genentech, won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis. Boehringer Ingelheim GmbH received approval for Pradaxa, a new type of blood-thinning drug to prevent strokes in patients with irregular heart rhythms. The company got a head start in a race among big drug makers to replace warfarin, an anticoagulent approved in 1954 that is still widely used. AstraZeneca PLC suffered a setback in that race when the FDA earlier this month asked for more information about a study backing its application for the blood-thinning drug Brilinta. The delay drove down AstraZeneca shares more than 5%. Patients with multiple sclerosis saw advances in treatment with the October approval of Novartis AG's Gilenya, an oral product. Multiple sclerosis has traditionally been treated by injections or infusions. Earlier in the year, the FDA also approved Acorda Therapeutics Inc.'s drug Ampyra to improve walking in MS patients.

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1/3/2011

com#printMode Page 2 of 2 In August. Provenge is designed to use a patient's own cells to stimulate the body's immune system to fight the cancer and may be the first in a new class of cancer-fighting drugs. after many years of concerns about an increased risk of serious abnormal heart rhythms. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. In addition to putting off a decision on Brilinta. the FDA also rejected a long-acting version of diabetes drug Byetta. A month later.djreprints.. For non-personal use or to order multiple copies. In October. Write to Jennifer Corbett Dooren at jennifer. Inc. and GlaxoSmithKline. 1/3/2011 . the FDA approved ella.corbett-dooren@dowjones. sold by Amylin Pharmaceuticals Inc. 2010 may be more notable for drugs that weren't approved. the makers of painkillers Darvon and Darvocet agreed to take those drugs off the market. as well as for drugs the agency restricted or pulled off the market. and Eli Lilly & Co.com/article/SB10001424052748704543004576052170335871018. please contact Dow Jones Reprints at 1-800-843-0008 or visit www. the FDA declined to approve two proposed weight-loss drugs from Arena Pharmaceuticals Inc. All Rights Reserved This copy is for your personal. It also said it needed until next March to review Benlysta.. a closely held company in Paris. The agency said this week it needed more time to review MannKind Corp. In April. saying more clinical data are needed to address cardiovascular safety concerns.New Drug Approvals Slipped in 2010 . In December. and was introduced in the U. saying the product didn't appear to help patients live longer.. The product was developed by HRA Pharma. which won't affect the use of Avastin in other types of cancer. a longer-lasting emergency contraceptive that's designed to block pregnancy up to five days after sex.com Copyright 2010 Dow Jones & Company.WSJ.com http://online. Roche is appealing the move. and Vivus Inc. non-commercial use only.html?m.'s inhaled-insulin product to treat diabetes.wsj. Dendreon Corp. a highly anticipated lupus drug from Human Genome Sciences Inc. In October. the agency removed Abbott Laboratories' weight-loss drug Meridia from 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 PLC's diabetes drug Avandia in September after it was linked to increased risks of heart attacks. the FDA said it would move to revoke the approval of Roche's cancer drug Avastin for use in breast cancer. However. earlier this month by Watson Pharmaceuticals Inc. saying the drug didn't work well enough to justify potential heart problems. won approval for its prostate cancer therapy Provenge.S. which had previously been rejected by the agency.

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