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Ilaris hits potholes

Ilaris safety in gouty arthritis could pose trouble for Novartis expansion plans

Novartis AG has been working on expanding the label for its Ilaris canakinumab to include multiple diseases beyond its approved Orphan indication of CAPS. But last week, an FDA panel voted against approval of the antibody for gouty arthritis due to safety concerns that also could show up in other indications the pharma is pursuing.

FDA's Arthritis Drugs Advisory Committee voted 11-1 against approval of Ilaris to treat gouty arthritis in patients who cannot obtain adequate responses with NSAIDs or colchicine. The panel also voted 12-0 against approval for the additional claim that Ilaris extends the time to the next attack and reduces the frequency of subsequent attacks.

It wasn't Ilaris' efficacy that concerned the panel: they voted 11-1 and 8-4 that efficacy data support the first and second claims, respectively.

The problem was lack of evidence supporting the antibody's safety. The panel voted 12-0 that Novartis had not sufficiently characterized Ilaris' safety profile because there were not enough data on repeated dosing, and there were increases in serious infections and serum uric acid levels after even a single dose in the Phase III trials.

In the real world, panelists said, patients would receive multiple injections.

An acute deficit

Ilaris is a human antibody against IL-1 beta that was approved in 2009 to treat cryopyrin-associated periodic syndrome

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