An FDA Advisory Panel has given Theravance's telavancin a tentative nod. Telavancin is the long-hoped for treatment for superbugs like methicillin-resistant Staphylococcus aureus (MRSA).
Although, it's very important to note that the FDA Panel has requested a risk management program for the drug and women of child-bearing age.
“Today's positive outcome is a significant milestone for telavancin, an important potential weapon against serious bacterial infections,” said Rick E Winningham, Chief Executive Officer of Theravance. “We will continue to work closely with the FDA as they complete their review of the telavancin NDA.”
It's worth noting that a positive advisory committee recommendation is not sufficient to receive FDA approval (evidenced by the FDA's decision on Dendreon's Provenge).
Although, it's very important to note that the FDA Panel has requested a risk management program for the drug and women of child-bearing age.
“Today's positive outcome is a significant milestone for telavancin, an important potential weapon against serious bacterial infections,” said Rick E Winningham, Chief Executive Officer of Theravance. “We will continue to work closely with the FDA as they complete their review of the telavancin NDA.”
It's worth noting that a positive advisory committee recommendation is not sufficient to receive FDA approval (evidenced by the FDA's decision on Dendreon's Provenge).
See Theravance press release