FDA wants more information on Novartis arthritis drug
pharmafile | August 31, 2011 | News story | Sales and Marketing | FDA, Ilaris, Novarits, canakinumab
The FDA has asked Novartis for more information on its gouty arthritis drug canakinumab.
The regulator’s request came in a Complete Response Letter in which it outlined the additional data needed, including clinical data to evaluate canakinumab’s risk-benefit profile in refractory patients.
The letter will come as little surprise to Novartis and follows FDA comments in June that it would need additional retreatment data to assess the overall safety profile of the drug.
Novartis said it remains committed to the drug, adding that the FDA did not have any concerns over canakinumab’s overall efficacy.
Novartis submitted its drug for regulatory review in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011.
These submissions were based on clinical trials that showed gouty arthritis patients treated with canakinumab at the time of an attack experienced superior pain relief at 72 hours and a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide.
The drug is already licenced to treat the auto-inflammatory disease Cryopyrin-Associated Periodic Syndrome in the US and EU under the trade name Ilaris.
But the delay will be a blow to Novartis who are hoping to increase the modest $26 million in sales it made from the drug last year.
The company is also looking to add juvenile rheumatoid arthritis to its licence, which it hopes will push the drug’s annual sales into the blockbuster realm.
Canakinumab is a fully human monoclonal antibody that neutralises interleukin-1 beta (IL-1 beta), and if approved would represent the first new class of therapies in nearly 50 years to treat the pain and inflammation of gouty arthritis.
Novartis has also filed the drug with the EMA, with a decision on its application for gouty arthritis patients with limited treatment options expected later this year.
Ben Adams
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