Biotech Values

[DewDiligence]

FDA Issues CRL for NVS’ Ilaris in Gouty Arthritis

[This action is consistent with the negative vote from the advisory panel two months ago (#msg-64476472). Ilaris (ACZ885) is already approved for the small indication known as CAPS; it will likely be approved for gout in due course, IMO, but it may take some time.]

http://www.novartis.com/newsroom/media-releases/en/2011/1541785.shtml

›August 29, 2011 07:15 CET

• Agency issues Complete Response letter requesting more data to support approval; Novartis will continue to work with the FDA on next steps

• Novartis remains committed to studying ACZ885 in inflammatory diseases where interleukin-1 beta plays a key role

Basel, August 29, 2011 - Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) as part of the US regulatory review for ACZ885 (canakinumab) in gouty arthritis patients. In its letter, the FDA requested additional information, including clinical data to evaluate the benefit risk profile in refractory patients.

On June 21, an advisory committee of the FDA voted in favor of the overall efficacy, but recommended that additional retreatment data would be needed to assess the overall safety profile of ACZ885.

Novartis submitted ACZ885 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 ACZ885 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 (TA).

ACZ885 was generally well tolerated in these studies, with most adverse events being mild to moderate in severity. Adverse events which included among others infections, were reported more frequently in patients treated with ACZ885 vs. those treated with TA.‹