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Getting Glucose Under Control
The US Food and Drug Administration (FDA) approved oral sitagliptin
phosphate 100 mg/d (Januvia), the first glucose-dependant dipeptidyl
peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes
when diet and exercise alone are insufficient. The drug is approved
both for monotherapy and for use with metformin or thiazolidinediones
to control glucose levels. In conjunction with the other medications,
the drug’s DPP-4 inhibition helps control insulin resistance,
decreased insulin release, and unsuppressed hepatic glucose production.
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Systemic Skin Treatment
Under the Orphan Drug Program, the FDA approved oral vorinostat (Zolinza) 400-mg
once daily for the treatment of cutaneous T-cell lymphoma manifestations
in patients with persistent, progressive, or recurrent disease after
two systemic therapy treatments. Cutaneous T-cell lymphoma is estimated
to affect up to 20,000 patients in the United States each year.
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A New Fighter for Lung Cancer
Originally approved in 2004 to treat colorectal cancer, the FDA has recently
approved
Genentech, Inc’s bevacizumab (Avastin) for a new indication.
The antiangiogenic drug, in combination with paclitaxel and carboplatin,
is now approved as a first-line treatment of unresectable, locally
advanced non–small-cell lung cancer. In a phase 3 study, survival
increased by an average of 2 months when bevacizumab was added to
chemotherapy regimens.
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Breathing a Little Easier
After more than 100 preclinical and 16 clinical studies, the FDA
approved a new drug from
Sepracor, Inc for the treatment of chronic obstructive pulmonary
disease (COPD). Arformoterol tartrate (Brovana) 15-mcg inhalation
solution is indicated for use twice daily for COPD, bronchitis,
and emphysema. It is the first FDA-approved ß2-agonist for
long-term treatment of COPD for use with a nebulizer.
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Breaking the Cycle of PMDD
The FDA granted a new indication approval for Berlex, Inc’s, drospirenone
(DRSP) 3 mg/ethinyl estradiol 20 mcg (Yaz) oral contraceptive (OC)
for the treatment of both emotional and physical symptoms of premenstrual
dysphoric disorder (PMDD). The 24-day active hormone regimen, in
conjunction with the 30-hour half-life of DRSP, results in less
hormonal fluctuation throughout the menstrual cycle. It is the first
OC to be approved for the treatment of PMDD, which is estimated
to affect 4.5 women in the United States
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