Drug Updates

Ticagrelor, another oral antiplatelet agent, recently garnered FDA approval for reducing thrombotic events in patients with acute coronary syndrome, including unstable angina, and patients with MI who are stenting candidates.⁹ Ticagrelor was studied in a dual antiplatelet regimen and comes with a boxed warning that aspirin doses greater than 100 mg daily can decrease its effectiveness. A Risk Evaluation and Mitigation Strategy was part of its approval, as has been the case with other recently FDA-approved antiplatelet agents. The agent was compared to clopidogrel, which had slightly lower bleeding rates. Clopidogrel is expected to lose patent protection in May 2012.

Pipeline Agents

AN2728 is a boron-based small molecule that inhibits phosphodiesterase-4 activity, thereby reducing the production of tumor necrosis factor–alpha, interleukin (IL)-12, IL-23, and other proinflammatory cytokines. It has received positive results from a phase IIb trial in psoriasis patients.¹⁰ It was studied in 68 patients with mild to moderate plaque-type psoriasis in a 12-week study and was compared with a placebo vehicle. A Physician’s Global Assessment score was used to determine outcomes. AN2728-treated patients showed improvement compared to placebo at all recorded time points during the study, with peak efficacy occurring after Day 42 of treatment. AN2728 is a 2% topical ointment. Phase III trials are planned.

BT-061 is an anti-CD4 antibody undergoing a phase II clinical trials for the treatment of RA and psoriasis.¹¹ It is also undergoing preclinical trials for other immune-mediated diseases. Abbott has entered into a partnership agreement with Biotest to develop and market this agent, to strengthen the Abbott immunology pipeline.

Canakinumab, an investigational IL-1-beta protein targeted monoclonal antibody, was deemed not approvable for acute gouty attacks by the FDA’s Arthritis Advisory Committee.¹² Safety issues, such as increased infection rates and high triglyceride levels, were of concern, considering it was felt that the agent would mainly be used for symptomatic relief rather than as a disease-modifying agent. The drug is already approved for use in patients with cryopyrin-associated periodic syndrome.

IMO-3100, an investigational TLR7 and TLR9 antagonist for psoriasis, is currently on clinical hold for proposed phase II clinical trials.¹³ A clinical hold, which is requested by the FDA, is used to delay a proposed trial or suspend an ongoing clinical trial. More data should be available soon.

Michele Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

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2. FDA Drug Safety Communication: Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events. www.fda.gov/Drugs/DrugSafety/ucm 264059.htm. Published July 21, 2011. Accessed July 27, 2011.
3. RITUXAN (rituximab)—fatal infusion related reactions in patients with rheumatoid arthritis—for health professionals. http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/ rituxan_6_hpc-cps-eng.php. Published June 2, 2011. Accessed June 29, 2011.
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8. Dane L. FDA approves Johnson & Johnson, Bayer’s Xarelto for DVT. www.firstwordpharma.com/node/883881. Published July 1, 2011. Accessed July 28, 2011.
9. Peck P. FDA okays new drug to prevent death, MI. www.medpagetoday.com/Cardiology/PCI/27647. Published July 20, 2011. Accessed July 22, 2011.
10. Anacor Pharmaceuticals announces positive preliminary results from Phase 2b trial of AN2728 for psoriasis. http:// inves tor.anacor.com/releasedetail.cfm?RELEASEID=587511&. Published June 27, 2011. Accessed July 28, 2011.
11. Dennis M. Abbott, Biotest enter deal for rheumatoid arthritis, psoriasis drug. www.firstwordpharma.com/forward/emailref?path=node/880228. Published June 21, 2011. Accessed July 28, 2011.
12. Gever J. FDA panel calls biologic drug unsafe for gout. www.medpagetoday.com/Rheumatology/Arthritis/27195?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news. Published June 21, 2011. Accessed June 21, 2011.
13. Idera reports clinical hold on proposed Phase 2 clinical trial of IMO-3100. http://ir.iderapharma.com/phoenix.zhtml?c=208904&p=irol-newsArticle_print&ID=1587275&highlight=. Published July 20, 2011. Accessed July 28, 2011.