FDA Panel Denies Gout Drug Ilaris (Novartis) ? Concern for Regeneron’s Arcalyst
The FDA’s Arthritis Advisory Committee recommended against approval of Novartis’ drug for Acute Gout, Ilaris (canakinumab), which is an anti IL-1 agent, proposed for the treatment of acute gout attacks, because of increased rates of infections, high triglyceride levels, and elevated uric acid levels.
This may have consequences for both Regeneron (Arcalyst-rilonacept) and Amgen (Kineret-anakinra), which share a basic underlying mechanism of anti IL-1.
The Acute Gout treatment paradigm includes: NSAIDs (which have had a plethora of
bad press about possible Cardiovascular complications); Colchicine which was previously available in multiple, very inexpensive, generic forms, and is now available only as the branded ColCrys (AR Scientific Inc.), which has come under fire for the dramatic price increase over the previously available generics; and Corticosteroids, parenterally or orally, which also have significant potential toxicity.
In a number of previously published studies, the Anti IL-1 drugs have been shown to be effective in treating and/or preventing Acute Gout flares, but the incidence of significant toxicity with Ilaris compared to the other drugs used in trials, led the Panel to assert that for “a drug predominantly used for symptomatic relief,” the incidence of serious toxicity was too high.
There continues to be a possible redirection for the use of these drugs as a longer term, preventative medication, particularly for patients who are unable to take or tolerate NSAIDs, Colchicine, or Corticosteroids.
The chronic treatment of Gout requires (in general) a lowering of the Serum Uric Acid (SUA), by:
1) Decreasing dietary intake; preventing dehydration2) Avoidance of medications that increase SUA: especially low dose aspirin and diuretics3) Decreasing intrinsic production: allopurinol, febuxostat (Uloric – Takeda), pegloticase
(Krystexxa – Savient Pharmaceuticals) – all currently availablea. Drugs currently in clinical pipeline, but not approved, including: pegsiticase (3 S Bio) and BCX4208 (BioCryst Pharmaceuticals)4) Increasing excretion of Uric Acid: probenecid (generic) and several others not available in the USa. Drugs currently in clinical pipeline, but not approved, including: RDEA594 (Lesinurad – Ardea Biosciences); Tranilast (Rizaben) – Nuon Therapeutics; MBX102 – Metabolex.The proper treatment of Gout necessitates the prevention of acute flares, while the uric
acid lowering therapies are initiated (since they can precipitate an acute attack), and are typically continued until the SUA has reached an acceptable level.It is for this effect that the Anti IL-1 drugs may have a better chance for approval in
patients who cannot take or tolerate NSAIDs, Colchicine, or Corticosteroids, and would clearly require longer term usage of these drugs than merely the treatment of a single acute attack.
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