New Drug Updates
The following drugs recently received approval from the U.S. Food and Drug Administration (FDA):
-Drug offers option for type 2 diabetes: Bristol-Myers Squibb in Princeton, NJ, recently announced it has received FDA approval for Glucovance (Glyburide and Metformin HCI tablets) for use along with diet and exercise, as initial drug therapy for people with type 2 diabetes. The drug also was approved as second-line therapy for people with type 2 diabetes who are currently taking either Glucophage (metformin hydrochloride tablets) or a sulfonylurea and a regimen of diet and exercise.
Glucovance will be available in three dosing strengths, including 1.25/250 mg, 2.5/500 mg, and 5/500 mg. The drug has proven safe in clinical trials but in rare cases may cause lactic acidosis in patients with kidney problems. It is also not indicated for patients older than 80, patients taking medication for heart failure, patients with a history of liver failure, or patients who drink excessive amounts of alcohol.
- Drug fights rejection in liver transplantation: Hoffmann-LaRoche in Nutley, NJ, recently received marketing clearance from the FDA for expanded use of CellCept (mycophenolate mofetil) for the prevention of organ rejection in patients undergoing liver transplantation. CellCept had been approved for use in kidney and heart transplantation.
In a double-blind, randomized study of 565 patients receiving liver transplants, the rate of death or retransplantation for CellCept was statistically better than azathioprine at six months and similar to azathioprine at one year, 14.7% vs. 14.6%. Patients enrolled in the study received 1 g twice daily CellCept intravenously for up to 14 days followed by mycophenolate mofetil 1.5 g twice daily orally, or azathioprine 1 mg to 2 mg intravenously, followed by azathioprine 1 mg to 2 mg in combination with cyclosporine and corticosteroids as maintenance immunosuppressive therapy.
- Drug treats two main causes of asthma: The FDA recently approved the first and only asthma medication that simultaneously treats both of the underlying components of the disease: inflammation and bronchoconstriction. Advair Diskus (fluticasone propionate and salmeterol inhalation powder) developed by Glaxo Wellcome in Research Triangle Park, NC, contains an inhaled corticosteroid to reduce swelling and irritation inside the lungs’ airways and an inhaled long-acting bronchodilator to help prevent tightening of the muscles that surround the airways.
The drug is indicated for long-term, twice-daily maintenance treatment of asthma in patients 12 and older. It is not indicated for the relief of acute bronchospasm. Patients take one inhalation twice daily, once in the morning and once at night, from the diskus, a breath-activated powder inhaler.
[For details on clinical trials of the drug, see: Kavuru M, Melemed J, Gross G, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2000; 105:1,108-1,116.]
- Drug treats pediatric arthritis: Pharmacia in Peapack, NJ, recently received FDA approval for a new indication for Azulfidine EN-tabs in the treatment of children ages six to 16 with juvenile rheumatoid arthritis involving five or more diseased joints who have failed to respond adequately to salicylates or other nonsteroidal anti-inflammatory drugs.
In a 24-week, randomized, double-blind, placebo-controlled clinical trial, Azulfidine was evaluated in children with juvenile rheumatoid arthritis. The trial showed that Azulfidine significantly reduced several clinical endpoints of joint disease, including the number and severity of swollen joints, number of active joints, and overall joint severity score compared with placebo.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content