Drug Topics - October 15, 2007 - (Page 4)

4 DRUG TOPICS OCTOBER 15, 2007 www.drugtopics.com Of Interest to Pharmacists Drugs in the pipeline for diabetes Dana Cassell first, “to decrease the natural degradation that occurs through the enzyme DPP-4; and second, to have it bind to serum albumin—the most abundant of the serum proteins—to prolong its half-life,” explained Moses. Thus, the drug will be suitable for once-daily subcutaIn the pipeline neous administration. •Vildagliptin (Galvus), Novartis Phase II data show liraglutide to be efficacious as Vildagliptin is an oral antidiabetic agent of the DPP- monotherapy for diabetes; a large phase III trial for 4 class, administered once daily. It works by restor- monotherapy is under way, and results will be available ing the physiological balance between glucagon and in first quarter 2008. In addition, liraglutide has been insulin. found to improve glycemic control when used in comIn February 2007, Novartis received an approv- bination with oral antidiabetic therapy, including metable letter from the Food & Drug Administration re- formin and a TZD. If trial results continue to come in questing additional information, which has delayed as anticipated, the drug could be approved for use across the drug’s approval. The drug is already approved and the spectrum of Type 2 diabetes. The current phase III available in Mexico and Brazil, and was approved by program does not include a combination with insulin, the European Union in September. Moses said. “It might make sense, and one can assume Rogelio Braceras, M.D., medical director, Novartis, that will be done later, although I can’t comment speciftold Drug Topics that clinical trials involving 8,500 pa- ically on that.” tients, with over 6,500 treated with Phase II data support liraglutide’s use Vildagliptin, have shown A1c reducfairly early in the course of the disease, tions of greater than 1% up to 1.8%. according to Moses. “The mechanism “We have data to prove its efficacy up of action of the incretin class would to two years,” said Braceras. suggest that it’s actually an ideal drug Data submitted to the FDA show early in the disease, but that again revildagliptin effective as monotherapy, mains to be seen from data—both with in patients not in control with a thia- Both Rogelio Braceras (l.) and exenatide [Byetta, Amylin Pharmaceuzolidinedione, and not in control Alan Moses are working on ticals and Eli Lilly & Co.] and with liwith a sulfonylurea. “We even have compounds to treat diabetes. raglutide,” Moses remarked. A compardata showing that when patients are not in control ative trial with exenatide has just begun, so results will with insulin, adding vildagliptin to their regimen de- not be available for some time. creases A1c further, plus decreasing hypoglycemia in Like exenatide, liraglutide produces weight loss. It those patients,” Braceras said. The drug has also been has a very low risk of hypoglycemia when used alone shown not to cause weight gain. or with agents that themselves do not cause hypoBraceras noted that clinical trials have included pop- glycemia. Its main side effects are gastrointestinal, and ulations across the spectrum. “Part of our clinical pro- it is administered via a pen device. Differentiating it gram goal was to show that vildagliptin is effective at from exenatide is liraglutide’s once-daily usage; plus, it any stage in the disease state, in different age groups, in can be taken at any time of the day, as long as it’s the different races, and in both the obese and non-obese.” same time day to day. “It certainly lowers fasting blood glucose lower than exenatide,” Moses added. •Liraglutide (trade name not yet announced), Novo Novo Nordisk expects to submit liraglutide for apNordisk proval to the FDA in 2008, with the hope that it will Liraglutide, an incretin, is a modification of human be approved during 2009. GLP-1. The modification has been made for two reasons, according to Alan Moses, M.D., chief medical offi- •Saxagliptin (trade name not yet announced), Ascer, North America, for Novo Nordisk. It has been made, traZeneca and Bristol-Myers Squibb ot only are there effective antidiabetes treatments on the market, but drugs in development promise to expand patient options even further. Listed below are some current candidates. N http://www.drugtopics.com

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Drug Topics - October 15, 2007 Contents Drugs in the Pipeline for Diabetes Vanquishing Med Errors from Abbreviations What Pharmacy Schools Never Taught You The Week at a Glance What Kinds of Mistakes Do Pharmacists Make?

Drug Topics - October 15, 2007

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