Drug Topics - October 29, 2007 - (Page 14)

14 DRUG TOPICS OCTOBER 29, 2007 www.drugtopics.com The Week at a Glance Reports prompt expanded Byetta precautions The FDA suspects the diabetes drug Byetta (exenatide, Amylin Pharmaceuticals) may be linked to cases of acute pancreatitis. The FDA said it has reviewed 30 reports of acute pancreatitis in patients taking exenatide and noted that an association between the drug and acute pancreatitis is suspected in “some of these cases.” Amylin has agreed to include information about acute pancreatitis in the Precautions section of the product’s label. The agency said doctors should advise patients taking exenatide to seek prompt medical care if they have unexplained, persistent, and severe abdominal pain that may or may not be accompanied by vomiting. Patients with suspected cases of pancreatitis should stop taking exenatide and not restart it until another cause for the abdominal pain is found, the FDA said. The oral capsules are indicated specifically for patients who have had a complete or partial response to firstline chemotherapy and are at least 45 days from the end of treatment. According to Glaxo, topotecan capsules are the only single-agent chemotherapy to be approved for the treatment of SCLC after failure of first-line therapy. The approval was based on results of a phase III trial that showed topotecan plus best supportive care (BSC) was associated with prolonged survival when compared with BSC care alone (25.9 weeks vs. 13.9 weeks). Topotecan is a topoisomerase inhibitor. According to the manufacturer, the oral capsules will be available in 2008. First integrase inhibitor Isentress gets regulatory green light Accelerated approval for Merck’s raltegravir (Isentress), www.insentress.com, the first in a new class of antiretrovirals called integrase inhibitors, has been granted by the FDA. The approval is for use in combination with other antiretrovirals for the treatment of HIV in treatment-experienced patients with evidence of resistance to multiple agents. The drug works by inhibiting the insertion of HIV DNA into human DNA by the integrase enzyme, thereby limiting the ability of the HIV virus to replicate and infect new cells. The agency’s decision was based on a 24-week analysis of clinical trials in which the addition of raltegravir to optimized background therapy (OBT) led to significant reductions in viral load and increased CD4 cell counts in treatmentexperienced patients. Merck said the wholesale acquisition cost of the new drug will be $27 per day, or roughly $9,900 per year. The AIDS Healthcare Foundation criticized Merck for the announced price, calling it symptomatic of the overall price spiral of AIDS drugs in general and out of reach for most AIDS patients. Merck called the price comparable to several available ritonavir-boosted protease inhibitors. Velcade now OK’d for patients with renal insufficiency Following submission of results from a phase I pharmacokinetics trial in patients with kidney impairment, Millennium Pharmaceuticals has announced FDA approval for an expanded label for bortezomib (Velcade). The treatment is now approved for use without dosage adjustments in patients with impaired kidney function, including those requiring dialysis. According to the company, the results of the recent study satisfy a post-approval commitment to the FDA required as part of the drug’s 2003 approval. Bortezomib is indicated for the treatment of both multiple myeloma and mantle cell lymphoma in patients who have received at least one prior therapy. Apria Healthcare Group, Coram to tie the knot Apria Healthcare Group and Coram Inc. have entered into a definitive merger agreement whereby Apria will acquire Coram. Coram is a privately held national provider of home infusion and specialty pharmaceutical services. The acquisition will expand Apria’s service offering by creating an enhanced nationwide home infusion provider. Apria provides home respiratory therapy, home infusion therapy, and home medical equipment through approximately 500 U.S. locations. The acquisition is expected to close as early as mid-November. Rite Aid and Lindora to open five clinics in southern California Rite Aid Corp. and Lindora Inc. plan to open five more Lindora Health Clinics inside Rite Aid stores in southern California. There are currently four Lindora Health Clinics in Rite Aid stores in Los Angeles and the Orange County area. The new clinics planned for Rite Aid in El Segundo, Encinitas, Santa Monica, and Tustin are expected to open by the end of the year, and a clinic is slated to open in San Diego by next spring. The clinics offer supervised weight management and traditional instore healthcare clinic services, including diagnosis and treatment of common illnesses. Priority review of Hycamtin leads to FDA nod for SCLC GlaxoSmithKline has received regulatory approval following priority review of topotecan (Hycamtin) for the treatment of relapsed small cell lung cancer (SCLC). http://www.drugtopics.com http://www.insentress.com

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Drug Topics - October 29, 2007 Contents N.J. R.Ph.s Take AMP Fight to Congress Oral Care Product Sales Holding Steady Still More Stellar Independent Pharmacies Students to Students: Check Out Our Book The Week at a Glance

Drug Topics - October 29, 2007

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