Recent FDA action (through August 2008) related to long-acting depot preparation of testosterone, pancrealipase capsules, human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant, tolvaptan, etanercept, ustekinumab, and cysteamine hydrocortisone dual-release table.
New indication: Bortezomib (Velcade), an antineoplastic agent, was approved on June 20, 2008, for the initial treatment of multiple myeloma.
Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus (August 2008)
The US orphan drug program has demonstrated that economic incentives and regulatory flexibility can spur development of treatments for small patient populations. Since enactment of the Orphan Drug Act (ODA) in 1983, FDA has approved >300 medicines for approximately 12 million patients around the world. However, there are approximately 6,000 to 8,000 rare diseases, so “we still have a very long way to go,” commented Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), at a May conference commemorating ODA’s 25th anniversary, which was sponsored by the Drug Information Association (DIA).
Hospital-acquired pneumonia (HAP) is a frequently occurring complication of endotracheal intubation and hospitalization that is associated with a significant increase in morbidity, mortality, and cost of care.
Tolvaptan is an oral selective vasopressin V2 receptor antagonist that works to produce aquaresis (water diuresis without electrolyte excretion) by blocking the effects of AVP. This effect makes tolvaptan a viable treatment option for patients with acute decompensated heart failure (ADHF) and hyponatremia.
Generic drugs approved by FDA (through July 2008) including fluoxetine capsules and calcipotriene topical solution.
Recent FDA action (through July 2008) related to tigecycline, bazedoxifene, balsalazide tablet, tacrolimus, fospropofol injection, bivalirudin, 13-valent pneumococcal conjugate vaccine, pirfenidone, LX1032, palifosfamide, SB1518, oral tetrathiomolybdate, and terguride.
Recent FDA approvals and indications (through July 2008) related to Abilify, Levaquin, Taclonex Scalp, Recothrom, and Seroquel.
New indication: Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor, was approved on May 7, 2008, for the maintenance treatment of ADHD in children and adolescents.
NME: Alvimopan (Entereg), a peripherally acting mu-opioid receptor antagonist, was approved on May 20, 2008, to accelerate the time to upper and lower GI recovery after partial large or small bowel resection surgery with primary anastomosis.
According to the results of an extended follow-up of the African American Study of Kidney Disease and Hypertension (AASK), long-term reduction of blood pressure to a lower goal than the standard demonstrates no significant effect on the progression of chronic kidney disease (CKD) in nondiabetic hypertensive patients, except in patients with baseline urinary protein/creatinine ratio >0.22, said Jackson Wright, MD, professor of medicine and director of the hypertension program at Case Western Reserve University, Cleveland. These results were presented at the 23rd Annual Scientific Meeting of the American Society of Hypertension, New Orleans, May 14–17, 2008.
Epoetin alfa in 1993 and darbepoetin alfa in 2002 were approved for the management of chemotherapy-induced anemia (CIA).
Drugs in development for the treatment of adult and juvenile rheumatoid arthritis
An investigational first-in-class dual angiotensin and endothelin receptor antagonist lowered systolic blood pressure (SBP) in patients with stage 1 and 2 hypertension in a phase 2a trial, reported Joel M. Neutel, MD, associate professor of medicine, University of California, Irvine, and medical director of clinical pharmacology, Orange County Research Center, Tustin, California. These results were presented at the 23rd Annual Scientific Meeting of the American Society of Hypertension, New Orleans, May 14–17, 2008.
The combination of amlodipine and olmesartan was demonstrated to be superior to monotherapy with either agent in difficult-to-treat hypertensive populations in a subgroup analysis of the registrational trial for this combination therapy. These results were presented at the 23rd Annual Scientific Meeting of the American Society of Hypertension, New Orleans, May 14–17, 2008.
Gut hormones play a key and often overlooked role in weight loss and weight regulation. Changes in weight are determined largely by the balance between energy intake and energy expenditure, but gut hormones can affect both sides of the energy equation.
The range of endothelial interventions for peripheral artery disease (PAD) is proliferating. Today's choices include traditional balloon angioplasty, stents, drug eluting stents and fabric-covered stents. Newer technologies allow clinicians to cut out occlusions, freeze them, scrape them, laser them and kill them.
Hyperglycemia is involved in the dysregulation of endothelial nitric oxide (NO) synthase, leading to endothelial dysfunction and an increased risk of vasculopathy, said Markku Laakso, MD.
Pramlintide injection added to basal insulin at mealtime is similar to titrated rapid-acting insulin in achieving glycemic control but with a lower risk of hypoglycemia and no weight gain in patients with type 2 diabetes, said Matthew Riddle, MD, head, section of diabetes, division of endocrinology/diabetes/clinical nutrition, Oregon Health and Sciences University, Portland.
Coronary artery calcium and abdominal aortic calcium both predicted future cardiovascular events in a Veterans Administration population with type 2 diabetes. The relationship between calcium scores and cardiovascular events was independent of standard cardiovascular risk factors, said Peter Reaven, MD.
Surrogate endpoints in clinical trials (ie, hemoglobin [Hb] A1c) on which drug approvals may be based only explain narrow aspects of complex conditions. For this reason, even when using a drug as labeled, there is always a level of uncertainty over outcomes with the drug, said Saul Malozowski, MD, PhD, MPH.
Clinicians should be wary of health claims made for trace elements such as iron or chromium. While there is no doubt that trace elements are needed for health, there is significant doubt about their utility in preventing or curing diabetes and other diseases, said Eliseo Guallar, MD, DrPH, Johns Hopkins Bloomberg School of Public Health, Baltimore. There are many hypotheses about the beneficial effects of trace elements, but little high-quality data, little reliable population data, few useful biomarkers, relatively crude analytical methods and few mechanistic studies.
Pioglitazone prevented progression to type 2 diabetes in patients with impaired glucose tolerance (IGT), reported Ralph DeFronzo, MD. The effect was marked?81% fewer patients assigned to pioglitazone compared with placebo converted from IGT to type 2 diabetes in a randomized, double-blind, placebo-controlled clinical study.
British women who have poorer glycemic control before and during pregnancy have poorer outcomes and less-healthy babies. That's the take home message from CEMACH, the Confidential Enquiry into Maternal and Child Health, a year-long survey of pregnant women with type 1 and type 2 diabetes across the United Kingdom.
Atherosclerosis and its complications develop in stages. Each of each of these stages is affected by different metabolic abnormalities, said Scott Grundy, MD, PhD, during the annual Edwin Bierman lecture.
