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Approvals Of New Drugs Down In 2010 Vs 2009, 2008

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The number of new drugs approved by the Food and Drug Administration in 2010 looks to be about 21, a relatively low 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 others got delayed partly reflecting a tougher regulatory environment amid ongoing concerns about drug safety. According to monthly drug-approval reports generated on FDA's website, 21 new types of drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007. Final approval figures as well as the number of applications received by the agency in 2010 won't be available until next month. Although the 2010 figures are a bit lower than previous years, the FDA said there's "no systemic change in how the FDA is approaching drug approvals." Sandy Walsh, an agency spokeswoman, noted that drug applications come in on a rolling basis making it difficult to compare one calendar year to another. She said the primary factor driving approvals "is the quality of the application and the quality of the data that support the drug's safety and efficacy." Amgen Inc. (AMGN) won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women while Roche Holding Ltd.'s (RHHBY) biotech unit, Genentech, won approval for Actemra, a drug that is administered intravenously to treat rheumatoid arthritis. Boehringer Ingelheim GmbH received approval for a new type of blood-thinning drug, Pradaxa, to prevent strokes in patients with irregular heart rhythms, potentially replacing much warfarin use, an old, widely-used anticoagulant approved in 1954. Patients with multiple sclerosis saw advances in treatment with the October approval of Novartis AG's (NVS) Gilenya, an oral product. Multiple sclerosis has traditionally been treated by injections or infusions. Earlier in the year, FDA also approved Acorda Therapeutics Inc.'s (ACOR) drug, Ampyra, to improve walking in MS patients. In August, the FDA approved ella, a longer lasting emergency contraceptive that is designed to block pregnancy up to five days after sex. The product was developed by HRA Pharma, a closely-held company in Paris, and was launched in the U.S. earlier this month by Watson Pharmaceuticals Inc. (WPI). In April Dendreon Corp. (DNDN) won approval for its prostate cancer therapy Provenge, which had previously been rejected by the agency. 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. However, 2010 may be more notable for drugs that weren't approved as well as for drugs the agency restricted or pulled off the market. The FDA refused to approve AstraZeneca PLC's (AZN) blood-thinning drug Brilinta and asked the company earlier this month for more information about one of the studies submitted in support of the product's approval. The also rejected a long-acting version of diabetes drug Byetta, sold by Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY), saying more clinical data is needed to address cardiovascular safety concerns. In October the FDA declined to approve two proposed weight-loss drugs from Arena Pharmaceuticals Inc. (ARNA) and Vivus Inc. (VVUS). 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 (GSK) diabetes drug Avandia in September after it was linked an increased risks of heart attacks. In October the agency removed Abbott Laboratories (ABT) weight-loss drug Meridia from the market, saying the drug didn't work well enough to justify potential heart problems. A month later the makers of decades-old painkillers Darvon and Darvocet agreed to take those drugs off the market on concerns about an increased risk of serious abnormal heart rhythms. In December, the FDA said it would move to revoke the approval of Roche's cancer drug Avastin for use in breast cancer saying the product didn't appear to help patients live longer. The decision won't affect use of Avastin in other types of cancers. The agency also delayed some decisions in 2010, saying this week it needed more time to review MannKind Corp.'s (MNKD) 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. (HGSI) and GlaxoSmithKline. --By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com.

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