New FDA Approvals

These drugs were recently approved by the FDA:

Deferasirox (Exjade) by Novartis Pharmaceutical Corp. The FDA has approved deferasirox (Exjade), an oral iron chelator developed to treat chronic iron overload due to multiple blood transfusions.

Deferasirox is the first orally administered medication to be approved for this use. Treatment for iron overload, which can damage the heart and liver, had previously required daily prolonged drug infusions lasting eight to 12 hours.

Deferasirox was approved under the FDA’s accelerated approval program. Companies are required to do further studies to verify the clinical benefits. In clinical studies of 48 weeks duration, deferasirox demonstrated reduction in liver iron concentration in adult and pediatric patients receiving red blood cell transfusions on an ongoing basis.

Deferasirox also received orphan drug designation. The Orphan Drug Act provides a seven-year period of exclusive U.S. marketing to the first sponsor that obtains marketing approval for a designated orphan drug.

In clinical studies, common side effects included nausea and abdominal pain. Elevations in blood tests that measure kidney and liver functions were also noted. Less common side effects included hearing and visual disturbances and rashes. Monitoring of laboratory tests measuring kidney and liver function and testing of hearing and vision before and during treatment are recommended.

Hyaluronidase human injection (Hylenex recombinant) by Halozyme Therapeutics. The FDA has approved hyaluronidase human injection (Hylenex recombinant) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. Baxter Healthcare Corp. will market and sell hyaluronidase human injection in the United States.

Hyaluronidase human injection is indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase human is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation.

Results from a clinical trial demonstrated no allergic reactions to hyaluronidase human injection and significantly reduced injection site discomfort. The double-blind clinical study compared hyaluronidase human injection to a saline control in 100 human volunteers. These volunteers were injected intradermally with hyaluronidase human injection in one forearm and saline control in the other forearm, and evaluated for allergic responses and injection site side effects. The data showed injection site discomfort of 28% in the saline arm and 3% in the hyaluronidase human injection arm.

West Nile Virus (WNV) blood test, developed by Gen-Probe and marketed by Chiron Corp. The FDA has approved the first West Nile Virus blood test to screen donors of blood, organs, cells, and tissues. The Procleix WNV Assay detects viral genetic material (ribonucleic acid or RNA).

This new test will help protect patients who receive blood and other such products against West Nile infection. To date, there have been 30 documented cases of people who most likely acquired WNV from a blood transfusion, including nine who died.

WNV is typically transmitted to humans by mosquito bites. It is estimated that between 1 million and 2 million people have been infected with WNV.

New indication for moxifloxacin HCl (Avelox) by Schering-Plough Corp. The FDA has approved the once-daily, broad-spectrum antibiotic moxifloxacin HCl (Avelox) for a new use — the treatment of complicated intra-abdominal infections (cIAI) in adults. Moxifloxacin is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication.

With this FDA approval, moxifloxacin is indicated for the treatment of adults with cIAI, including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostrepto-coccus species.

The FDA approval was based on results from clinical studies in cIAI patients showing that sequential intravenous (IV) or oral monotherapy with moxifloxacin once daily was as effective as the widely used IV therapy piperacillin-tazobactam four times daily followed by oral amoxicillin-clavulanate twice daily.

Patients taking moxifloxacin for cIAI treatment do not require dosage adjustments when switching from IV to oral therapy. Dosage adjustments also are not required for moxifloxacin patients suffering from renal impairment.

Moxifloxacin was developed by Bayer Pharmaceuticals Corp. and is marketed in the United States by Schering-Plough.