NeurogesX’s Qutenza Can’t Get Past 30 Minutes At Advisory Committee
This article was originally published in The Pink Sheet Daily
The specter of future drug sponsors with weak efficacy evidence besieging FDA helped persuade the Anesthetic and Analgesic Drug Products Advisory Committee to unanimously reject Qutenza (capsaicin 8%) patch for treatment of pain from HIV neuropathy.
You may also be interested in...
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.