FDA panel endorses efficacy but not safety of Novartis drug ACZ885 for gouty arthritis; did not support approval in proposed indication
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FDA panel endorses efficacy but not safety of Novartis drug ACZ885 for gouty
arthritis; did not support approval in proposed indication
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* Advisory committee strongly endorsed the efficacy of ACZ885 (canakinumab)
* Committee voted against approval of ACZ885 for proposed indication;
potential identified for use in more narrow patient population
* Gouty arthritis is a chronic and progressive inflammatory disease of the
joints characterized by recurrent attacks of severe pain[1], lasting a week
or more[2]
Basel, June 21, 2011 - An advisory committee of the Food and Drug Administration
(FDA) today voted in favor of the overall efficacy but not the overall safety of
ACZ885 (canakinumab) to treat gouty arthritis attacks in patients who cannot
obtain adequate relief with non-steroidal anti-inflammatory drugs (NSAIDs) or
colchicine. Committee members raised the potential for use in a more narrow
population of gouty arthritis patients.
ACZ885, a fully human monoclonal antibody that neutralizes interleukin-1 beta
(IL-1 beta)[3], would represent the first new class of therapies in nearly half
a century to treat the pain and inflammation of gouty arthritis. Excessive
production of IL-1 beta is believed to play a major role in many inflammatory
diseases, including gouty arthritis[4].
"We continue to believe in the benefits of ACZ885 for this painful and
debilitating disease and will work closely with the FDA to identify the right
patient population who will benefit from this therapy," said Trevor Mundel, MD,
Global Head of Development at Novartis Pharmaceuticals. "We are encouraged by
the committee's enthusiasm and robust discussion and remain committed to
addressing the needs of people with gouty arthritis."
The committee's recommendation will be considered by the FDA in its review of
the supplemental biologics license application (sBLA) that Novartis submitted
for ACZ885. The FDA has the option of seeking the advice of its advisory
committees when it is reviewing a new drug approval, although it is not obliged
to follow the recommendations.
The recommendation by the committee was based on the results of two pivotal
Phase III trials in patients with gouty arthritis. The studies showed patients
treated with ACZ885 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)[5].
Gouty arthritis is the most common form of inflammatory arthritis in adults[6].
Chronic and progressive, the disease is characterized by recurrent attacks in
the joints[1]. These attacks occur when the body has a strong inflammatory
response to uric acid crystals forming in the affected joint, typically of the
toe, foot, ankle, or knee[1],[7]. The intense inflammatory response associated
with these attacks may cause severe pain and debilitating symptoms that can last
a week or more[1],[2],[7].
About ACZ885 Phase III Studies
The committee reviewed results of two pivotal Phase III studies in which the
efficacy of ACZ885 150 mg over 24 weeks was studied in more than 450 gouty
arthritis patients. Both trials used an internationally recognized pain scale to
measure differences in pain 72 hours after treatment. Patients treated with
ACZ885 had a significantly lower mean pain score - a 49.1 millimeter (mm)
decrease from baseline - resulting in a statistically significant and clinically
meaningful 10.7 mm difference (p<0.0001) compared to TA 40 mg[5]. Patients
receiving ACZ885 also experienced a significant reduction in the relative risk
of suffering a new gouty arthritis attack within 24 weeks, by 56%, compared to
patients receiving TA (p<0.0001)[5]. Importantly, only 28% of patients treated
with ACZ885 experienced new attacks over 24 weeks compared to 49% treated with
TA[5].
ACZ885 was generally well tolerated in the two studies, with most adverse events
being mild to moderate in severity[5]. Across both studies, 69.6% of patients
had adverse events (AEs) with ACZ885 vs. 57% with TA[5]. Serious events (SAEs)
were reported by 18 patients treated with ACZ885 vs. nine patients on TA[5].
None of the SAEs were considered by clinical investigators to be related to
study medication[5].
About Gouty Arthritis
Gouty arthritis, commonly referred to as gout, is a painful and debilitating
inflammatory disease that affects up to 8.3 million Americans[1],[6],[7]. The
most common form of inflammatory arthritis in adults, gouty arthritis is
estimated to be five times more prevalent than rheumatoid arthritis in the
US[8],[9].
Treatments currently available to manage the pain and inflammation of gouty
arthritis attacks, such as NSAIDs or colchicine, may be inadequate or
inappropriate in patients who have certain coexisting medical
problems[2],[10],[11]. As a result, there is a significant unmet medical need
among individuals with gouty arthritis. In the US, over 95% of gouty arthritis
patients or those with high levels of uric acid (hyperuricemia) have at least
one coexisting disease[12].
About ACZ885
Regulatory filings for the use of ACZ885 in gouty arthritis patients with
limited treatment options were submitted in the EU in 2010 and in the US, Canada
and Switzerland in the first quarter of 2011. ACZ885 is being assessed by the
FDA with a priority review voucher (PRV), which expedites review time from 10 to
six months. A decision is expected in the third quarter of 2011.
Under the brand name Ilaris(®), ACZ885 is approved in more than 45 countries,
including the EU, US and Switzerland for the treatment of adults and children as
young as four with Cryopyrin-Associated Periodic Syndromes (CAPS), a rare,
lifelong, inflammatory disorder with debilitating symptoms[3]. ACZ885 is also
being studied in other diseases in which IL-1 beta plays a key role in causing
inflammation, such as Systemic Juvenile Idiopathic Arthritis (SJIA),
cardiovascular disease and diabetes. Not all potential patients with these
diseases would be eligible for treatment with ACZ885, if approved.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "would," "believed," "will," "encouraged,"
"committed," "recommendation," "priority review," "expected," or similar
expressions, or by express or implied discussions regarding potential new
indications or labeling for ACZ885 or regarding potential future revenues from
ACZ885. You should not place undue reliance on these statements. Such forward-
looking statements reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties and other factors
that may cause actual results with ACZ885 to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that ACZ885 will be submitted or approved
for any additional indications or labeling in any market, or at any particular
time. Nor can there be any guarantee that ACZ885 will achieve any particular
levels of revenue in the future. In particular, management's expectations
regarding ACZ885 could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected additional
analysis of existing clinical data; competition in general; government, industry
and general public pricing pressures; the company's ability to obtain or
maintain patent or other proprietary intellectual property protection, the
impact that the foregoing factors could have on the values attributed to the
Novartis Group's assets and liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in Novartis AG's current
Form 20-F on file with the US Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
anticipated, believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not undertake any
obligation to update any forward-looking statements contained in this press
release as a result of new information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only company with leading
positions in these areas. In 2010, the Group's continuing operations achieved
net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 119,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
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References
1. Schumacher HR Jr. The pathogenesis of gout. Cleve Clin J Med.
2008;75(5):S2-4.
2. So A, De Meulemeester M, Pikhlak EA, et al. Canakinumab for the treatment of
acute flares in difficult-to-treat gouty arthritis. Arthritis Rheum.
2010;62(10):3064-76.
3. ILARIS [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals
Corp; 2009.
4. Church LD, Cook GP, McDermott MF. Primer: inflammasomes and interleukin 1
beta in inflammatory disorders. Nat Clin Pract Rheumatol. 2008; 4(1):34-42.
5. Novartis FDA Briefing Book, Arthritis Advisory Committee Meeting. June
21, 2011
6. Zhu Y, Pandya B, Choi H. Increasing gout prevalence in the US over the last
two decades: The National Health and Nutrition Examination Survey (NHANES).
Presented at: The American College of Rheumatology Annual Scientific
Meeting; 2010 Oct; Atlanta, GA.
7. Mandell BF. Clinical manifestations of hyperuricemia and gout. Cleve Clin J
Med. 2008; 75(5):S5-8.
8. So A. Developmens in the scientific and clinical understanding of gout.
Arthritis Res Ther. 2008; 10(5):221.Myasoedova E, Crowson CS, Kremers HMet
al. Is the incidence of rheumatoid arthritis rising?: results from Olmsted
County, Minnesota, 1955-2007. Arthritis Rheum. 2010;62(6):1576-1582.
9. Schlesinger N, Dalbeth N, Perez-Ruiz F. Gout-what are the treatment options?
Expert Opin Pharmacother. 2009;10:1319-28.
10. Jordan KM, Cameron JS, Snaith M, et al. British Society for Rheumatology and
British Health Professionals in Rheumatology guideline for the management of
gout. Rheumatology. 2007;46:1372-4.
11. Riedel AA, Nelson M, Wallace K, Joseph-Ridge N, Cleary M, Fam AG. Prevalence
of comorbid conditions and prescription medication use among patients with
gout and hyperuricemia in a managed care setting. J Clin Rheumatol.
2004;10(6):308-14.
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