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FDA advisory committee recommends approval for Cinqair in adults only
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 11-3 to recommend approval for Cinqair in patients aged 18 years and older.
Cinqair (reslizumab, Teva) is a humanized monoclonal antibody that targets human interleukin 5 intended for patients with asthma too severe to be treated by high-dose inhaled corticosteroids.
Voters approved reslizumab (Cinqair, Teva) for the indication of 3 mg/kg through IV once every 4 weeks. They did not approve reslizumab for the same indication for adolescents aged 12 to 17 years, citing that there were not enough efficacy or safety data to make a recommendation in that age group.
“For me this was an easy one,” Erica Brittain, PhD, mathematical statistician at the National Institute of Allergy and Infectious Diseases of the NIH, said at the committee meeting. “There was clearly no substantial evidence.”
James K. Stoller, MD, professor and chairman at the Cleveland Clinic, added, “If there is a specific desire for labeling indication in this group, there ought to be a decisive study that includes patients in these age ranges to look at, not as a subset of a larger study.”
The same three committee members who voted against final approval also voted against the overall safety of the drug, citing concerns with anaphylaxis and elevated creatine phosphokinase (CPK) levels.
“I think this is a drug that clinicians will probably use very cautiously, and maybe will improvise so they watch CPK and will by very vigilant about anaphylaxis,” Dennis R. Ownby, MD, professor of pediatrics at Georgia Regents University, said at the meeting. “So, I am placing faith on our practicing physicians that this will not be a major problem.”
Reslizumab was tested across five double blind, placebo controlled studies, including two yearlong clinical trials. In all studies, researchers looked at 3 mg/kg IV doses of reslizumab given once monthly to patients with moderate to severe asthma and baseline blood eosinophil counts greater than or equal to 400 per µL and who were already receiving high-dose inhaled corticosteroid treatment. Across the five studies, only 39 patients aged between 12 and 17 years were tested.
In the two yearlong trials, reslizumab decreased the rate of asthma exacerbation by 50% and 59% (RR = 0.5; 95% CI, 0.37-0.67; P < .0001 and RR = 0.41; 95% CI, 0.28-0.59; P < .0001, respectively).
In all studies, patients in the reslizumab groups (67%) experienced lower overall incidences of adverse events vs. placebo groups (81%). However, there were two safety concerns. Among the 1,311 patients in the five studies, there were five cases of anaphylaxis, three of which were related to the treatment, and none that occurred in the placebo groups. In all studies, CPK elevation occurred twice as often in reslizumab groups (0.8%) than in placebo groups (0.4%).
The FDA is not required to follow the advice of its advisory committees, but it normally does. – by Will Offit
Reference:
PADAC FDA Clinical Briefing Document. BLA 761033.