UPDATE ON DRUGS
|Class||Name/Company||Approval Dates and Comments|
|Zoster Vaccine Live|
|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.
|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.
|Meropenem for Injection|
|The US FDA approved this antibiotic in May 2005 for the|
treatment of complicated skin and skin structure infections in
adults and children.
|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.
|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.
|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.