Canadian biopharma Isotechnika sounds like it is bracing for an FDA "complete response" letter after the agency's last-minute announcement that it is cancelling a June 28 meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee that was set to review the company's drug voclosporin to treat uveitis.

"This meeting has been cancelled to allow time for the resolution of several outstanding issues," FDA said. "The agency intends to continue evaluating NDA 22340 and, as needed, may schedule an advisory committee meeting in the future."

The NDA for the drug was submitted under the trade name Luveniq by Isotechnika's partner Lux Biosciences, which has in-licensed the drug for ophthalmic indications. The advisory committee cancellation is a significant setback for a drug that FDA had granted priority review status and that has been cross-filed with the European Medicines Agency.

"At this time, the FDA has not communicated all the outstanding issues to Lux for the uveitis application," Robert Foster, Isotechnika president and CEO, said in a statement. "They await the action letter from the FDA which is expected on or near the PDUFA date of Aug. 3, 2010 for further clarification."

Luveniq would be the first new treatment for uveitis since corticosteroids became the standard treatment in the 1960s, but renal and blood pressure adverse effects may be raising questions in FDA reviewers' minds (Also see "Luveniq Advisory Committee: Renal Side Effects May Be Key Issue With Immunosuppressant" - Pink Sheet, 10 May, 2010.). In two clinical trials in which patients took the drug twice daily at a dose of 0.4 mg/kg, 8.2 percent of subjects experienced adverse effects on renal function - a decrease from baseline of 30 percent or more in glomerular filtration rate and twice the rate of those on placebo.

Isotechnika discovered voclosporin and is currently studying it for the treatment of psoriasis and the prevention of organ rejection in kidney transplant patients.

Safety Or Data Integrity?

But the problems Lux and Isotechnika face, and which led FDA to cancel the advisory committee meeting, may go beyond safety concerns. In another recent instance where the agency cancelled an advisory committee meeting just days before it was to be held, data integrity questions were at stake.

FDA's Division of Scientific Investigation raised questions about a contract research organization's oversight of clinical sites in studies of Theravance's antibiotic Vibativ (telavancin), so the agency called off the Anti-Infective Drugs Advisory Committee review of the antibiotic for complicated skin and skin structure infections, which had been scheduled for Feb. 27, 2008, on just two days' notice. (Also see "Burned By Ketek, FDA Took Care With Possible Data Integrity Issues For Telavancin" - Pink Sheet, 1 January, 2010.)

The trigger for the cancellation in that case was "unresolved issues from an inspectional standpoint (i.e., monitoring and conduct of studies)," Office of Antimicrobial Products Director Edward Cox told Theravance lawyers during a Feb. 25, 2008 teleconference, according to minutes of the session.

- Martin Berman-Gorvine (m.berman-gorvine@elsevier.com)

Last-Minute Cancellation Of Advisory Panel Meeting Throws Future of Luveniq Into Doubt

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