New FDA Approvals
These drugs recently were approved by the FDA:
- Lanthanum carbonate (Fosrenol) by Shire Pharmaceuticals Group plc. The FDA has approved lanthanum carbonate (Fosrenol), a new phosphate binder that reduces elevated blood levels of phosphate in patients with end-stage renal disease (ESRD). The U.S. approval follows Swedish regulatory approval for lanthanum carbonate granted in March this year.
In clinical trials involving ESRD patients treated with lanthanum carbonate, reductions in serum phosphorus were noted one week after starting therapy and the majority of patients reached target levels within eight weeks per the clinical trial design. Maintenance of reduction has been observed for up to three years in patients treated with lanthanum carbonate in long-term, open-label extensions.
In long-term open-label studies, 14% of the lanthanum carbonate-treated patients dropped out due to adverse events. In addition, bone biopsies taken from patients who had been treated with lanthanum carbonate for up to two years, showed that patients maintained their bone health status throughout the course of treatment.
Lanthanum carbonate is formulated as a chewable-only tablet that can be taken without water. Lanthanum carbonate will be available in 250 mg and 500 mg strengths. The recommended initial daily dose of lanthanum carbonate is 750-1,500 mg for adults; physicians should adjust the dose to reach target serum phosphorus levels. Most patients require a total daily dose between 1,500 mg and 3,000 mg to achieve serum phosphorus control, which equates to one to two lanthanum carbonate tablets per meal. The daily dose should be divided and taken with meals and snacks.
- New indication for infliximab (Remicade) by Centocor. The FDA has approved an expanded label for infliximab (Remicade) in combination with methotrexate, as a first-line regimen to treat patients with moderate to severe rheumatoid arthritis (RA). The expanded label eliminates the requirement that patients must fail to respond to methotrexate, the current standard of treatment for RA, before starting on the infliximab regimen.
The most commonly reported adverse events were upper respiratory infection, nausea, and headache. Serious infections included pneumonia, tuberculosis, and sepsis.
- New indication for letrozole tablets (Femara) by Novartis. The FDA has approved letrozole tablets (Femara) for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received adjuvant tamoxifen therapy for five years.
The approval for the extended adjuvant indication was based on results from the international, independent MA-17 study. The study showed that letrozole reduced the risk of cancer coming back by 38% and significantly increased a woman’s chance of staying cancer-free. Letrozole also reduced the chance of breast cancer returning to another part of the body by 39%.
Letrozole, a once-a-day oral aromatase inhibitor, also is indicated for first-line treatment of postmenopausal women with hormone receptor- positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Side effects commonly reported with letrozole generally are mild to moderate. In the extended adjuvant setting, those seen more often with letrozole than with placebo are hot flashes (50% to 43%) arthralgia/arthritis (29% vs. 23%), and myalgia (7% vs. 5%). In a clinical trial, osteoporosis was reported more frequently with letrozole than with placebo (7% vs. 6%). During treatment, both arms of the trial showed expected modest decreases in bone mineral density in the hip and spine.
Letrozole also may cause fetal harm when administered to pregnant women.Lanthanum carbonate (Fosrenol) by Shire Pharmaceuticals Group, New indication for infliximab (Remicade) by Centocor, New indication for letrozole tablets (Femara) by Novartis.
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