FDA: Theravance Must Fix GMP Before Drug Approval

Biopharmaceutical company required to resolve issues with good manufacturing practices compliance at a third-party manufacturer.

SOUTH SAN FRANCISCO, Calif. (AP) â€” Biopharmaceutical company Theravance Inc. said Monday it received an ''approvable'' letter from the Food and Drug Administration for its drug candidate telavancin, a once-daily injectable antibiotic for the treatment of skin infections caused by bacteria such as ''superbug'' staph infections.
The FDA's letter requires that Theravance resolve issues with good manufacturing practices compliance at a third-party manufacturer and submit revised labeling, additional clinical data or reanalyze clinical data, before the drug can be approved.
Theravance and partner Astellas said they believe no additional clinical studies will be needed to respond to the letter.
''We are committed to submitting a timely and complete response to this approvable letter,'' said Rick E. Winningham, chief executive of Theravance. ''We will work with the FDA to resolve the outstanding issues and to ensure a label that accurately reflects the data from our clinical studies, which included the largest group of patients with cSSSI and the largest group of patients infected with MRSA (superbug staph) ever studied.''
Recent reports from the Centers for Disease Control and Prevention, which were the subject of an article and editorial in the Journal of the American Medical Association, have estimated that more people may die of antibiotic-resistant staph or ''superbug'' infections than from the AIDS virus.
Currently, there are few drugs on the market to treat resistant staph infections.
In November 2005, Theravance teamed with Astellas Pharma Inc. to develop and market telavancin worldwide except in Japan, and in July 2006, expanded the partnership to include Japan. Theravance will lead the development of telavancin for the treatment of cSSSI and hospital-acquired pneumonia, and will collaborate with Astellas in marketing in the United States for the first three years.
Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities.
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