FDA issues Complete Response letter for Avodart sNDA for reduction of prostate cancer risk

GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart?® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

The authors describe developing a fusion protein from recombinant KGF and elastin-like-peptides, which are major constituents of skin and other connective tissues. Laboratory experiments showed that the fusion protein retained the wound-healing properties of both elastin and KGF and that it rapidly and efficiently self-assembled into nanoparticles in response to a simple increase in temperature. When applied to deep skin wounds in genetically diabetic mice, the nanoparticles accelerated healing by stimulating the formation of both surface epithelial tissue and thick fibrous connective tissue.

"This technology has great potential because the fusion protein can be easily manufactured at a relatively low cost, is easy to administer and does not disappear as readily as the growth factor alone," explains Martin Yarmush, MD, PhD, director of the MGH Center for Engineering in Medicine and senior author of the study. "The technology also provides a platform for delivery of any growth factor or combination of factors. One could imagine administering a mixture of nanoparticles, each with a different factor, or a single set of nanoparticles with a mixture of fusion proteins on each."

Source: Massachusetts General Hospital

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