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Update on Drugs & Drug News

UPDATE ON DRUGS

Class

Name/Company

Approval Dates and Comments

Antiviral Agent

Zoster Vaccine Live
Zostavax™
Oka/Merck

The US FDA received a Biologics License Application in April 2005 for this investigational vaccine for the prevention of herpes zoster, the prevention of postherpetic neuralgia, and the reduction of acute and chronic shingles-associated pain in adults.

Wound Management

Antimicrobial Barrier Dressing
ACTICOAT* Moisture Control
Smith & Nephew

The US FDA approved this product in May 2005 for wound care as a barrier to bacterial penetration, featuring the patented Silcryst™ nanocrystalline silver technology.

Antibacterial Agent

Meropenem for Injection
MERREM®
AstraZeneca

The US FDA approved this antibiotic in May 2005 for the treatment of complicated skin and skin structure infections in adults and children.

Antipsoriatic Agent

Etanercept
Enbrel®
Amgen/Wyeth Pharmaceuticals

The US FDA approved an additional indication for this tumor necrosis factor receptor in June 2005 to improve physical function in patients with psoriatic arthritis.

Drug News

Cancer Vaccine

CancerVax, in April 2005, announced plans to discontinue the Phase III clinical trial of Canvaxin™ in patients with Stage IV melanoma on the basis of the recommendation of the Independent Data and Safety Monitoring Board (DSMB). The DSMB, after a limited review of the trial found that the data are unlikely to provide significant evidence of a survival benefit for Canvaxin-treated patients with Stage IV melanoma vs. those receiving placebo. There were no safety issues identified, and the recommendation to close the study was not made because of any potential safety concern. It is anticipated that the final analysis of data from this clinical trial will take place after the required number of clinical events have occurred, currently estimated to take place in mid-2006.

Antipsoriatic Agent

Serono, in April 2005, announced the discontinuation of a Phase III clinical trial program for onercept (recombinant tumor necrosis factor binding protein) in moderate-to-severe psoriasis. Investigators reported two patients who were diagnosed with sepsis, one of whom subsequently died. Sepsis is a recognized potential risk for patients treated with anti-tumor necrosis factor therapies. The Independent Data and Safety Monitoring Board (DSMB) evaluated the available blinded efficacy data at 12 weeks, and data from the first 12 weeks of an open-label trial. Based on these aggregate data, they determined that the efficacy response observed for onercept was less than that observed in the earlier phase II trial, and with other available treatments. As a consequence of its unfavorable risk-benefit profile, the DSMB recommended discontinuation of the clinical development of onercept in moderate-to-severe psoriasis.


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