New FDA Approvals
September 1, 2003
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• New indication for etanercept (Enbrel), which is manufactured by Immunex Corp. and marketed by Amgen and Wyeth Pharmaceuticals. The FDA has approved etanercept (Enbrel) — 25 mg twice weekly — for a new indication for treatment of patients with active ankylosing spondylitis (AS).
The FDA’s decision follows an expedited review. Etanercept also is licensed for treatment of patients with rheumatoid arthritis, juvenile rheumatoid arthritis, and psoriatic arthritis.
The approved labeling warns physicians about post-marketing reports of serious infections. The labeling says that Enbrel should not be given to patients with any active infection, including chronic or localized infections. It also recommends that patients who develop a new infection while being treated with etanercept should be monitored closely.
Amgen will continue to follow patients in the trial to evaluate the long-term safety of etanercept in patients with AS.
• New indication for Somatropin, rDNA origin, for injection (Humatrope) by Eli Lilly Co. The FDA has approved somatropin, rDNA origin, for injection (Humatrope), a brand of growth hormone, for the long-term treatment of children with idiopathic (of unknown origin) short stature, also called nongrowth hormone-deficient short stature.
The American Association of Clinical Endocri-nologists and the Growth Hormone Research Society have defined "short stature" as height more than two standard deviations (SD) below the mean for age and sex. This corresponds to the shortest 2.3% of children. This new indication restricts therapy to children who are even shorter, specifically more than 2.25 SD below the mean for age and sex, or the shortest 1.2% of children. For example, for 10-year-old boys and girls, this would correspond to heights of less than 4’ 1". This would further correspond to heights of less than 5’ 3" and 4’ 11" in adult men and women, respectively. The new indication for idiopathic short stature is the first indication for growth hormone in children that specifies a height restriction.
The manufacturer says it will limit the marketing for this new indication to pediatric endocrinologists to better ensure the proper use of this product in the indicated pediatric population. In addition, the manufacturer intends to control tightly the distribution of Humatrope.
• Porfimer sodium (Photofrin) by Axcan Pharma. The FDA has approved porfimer sodium (Photofrin photodynamic therapy) injection for in the ablation of High-Grade Dysplasia in Barrett’s Esophagus patients who do not undergo esopha-gectomy. The drug also was granted orphan drug designation for this indication, which guarantees a seven-year marketing exclusivity.
Side effects of the drug treatment include photosensitivity reactions and esophageal strictures. The labeling includes information on precautions that should be taken to avoid exposure of skin and eyes to bright light.
• Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM) [Advate] by Baxter Healthcare Corp. The FDA has licensed a new recombinant DNA-derived clotting factor to treat people with hemophilia A. This new antihemophilic human factor VIII product is the first one produced without using additives derived from human or animal blood in the manufacturing process. The FDA says this advancement provides added reassurance against any theoretical infectious risks that may arise from the use of blood-derived additives in the manufacturing of factor VIII.
rAHF-PFM is approved to prevent and control bleeding episodes or to prepare persons with hemophilia for surgery. It is produced by genetically engineered Chinese hamster ovary cells that have been altered to produce factor VIII.
• New low dose of conjugated estrogens [CE]/ medroxyprogesterone acetate [MPA] tablet (Prempro) by Wyeth Pharmaceuticals. The FDA has approved a new low-dose strength of conjugated estrogens [CE]/ medroxyprogesterone acetate [MPA] tablets (Prempro), containing 0.3 mg CE and 1.5 mg MPA. Prempro 0.3 mg/1.5 mg is approved for the treatment of moderate-to-severe symptoms associated with menopause, such as hot flashes, night sweats, and vaginal dryness; and for the prevention of postmenopausal osteoporosis.
Wyeth also announced that the FDA has expanded the approved uses for Prempro 0.45 mg/1.5 mg to include the prevention of postmenopausal osteoporosis.
• Ciprodex Otic, a topical treatment of ciprofloxacin and dexamethasone, by Alcon. The FDA has approved Ciprodex Otic, a topical treatment of ciprofloxacin and dexamethasone, for a middle ear infection known as acute otitis media with tympanostomy tubes in children ages 6 months and older.
The FDA also approved Ciprodex Otic for the topical treatment of acute otitis externa (AOE). The AOE indication is for pediatric, adult, and elderly patients.
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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