Monday, March 28, 2016

An Asthma Drug Candidate First Mentioned In A Published Journal In 1997 -- Finally Clears FDA (SCH-55700): Now Teva's Cinqair® (Reslizumab)

First: Kudos go to our erstwhile anonymous commenter -- for alerting us to this approval, which was announced late last week! Now, to be clear, the delay here lies not at the the feet of the agency. No, this long, winding and checkered path has as much to do with the drug candidate's side effects, and relatively-narrowed indications -- for only truly severe asthma patients -- as it does to do with the number of times the program was moth-balled, and then restarted at various companies. [This long-awaited good news on reslizumab does belong here, though -- as a legacy Fred Hassan-era Schering Plough drug candidate.]

As it happens, this was a long lost legacy Schering-Plough candidate (then called SCH-55700) that fell into the abyss in the early 2000s, only to be acquired by Teva. Now, some ten years after Teva's acquision, it has finally been approved by the US FDA, for severe asthma. It will be one of a few drugs of like class, on market here in 2016 in the US. Below is a bit from the Advisory Committee materials of last December, and the the press release announcing approval may be found here.

. . . .Reslizumab is a humanized monoclonal antibody (IgG4, Kappa, mAb) that binds to human interleukin 5 (IL-5). While several cytokines can affect eosinophils, IL-5 is the main cytokine involved in the regulation of blood and tissue eosinophils.1 Cinqair (reslizumab) for injection is not currently marketed in the United States or any other country in the world. However, another monoclonal antibody targeting IL-5 (mepolizumab, BLA 125526) was recently approved on November 4, 2015, and was discussed at a PADAC on June 11, 2015. Mepolizumab is approved as add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. While the reslizumab program has also studied asthma patients with an eosinophilic phenotype, the proposed indication includes patients of a lesser disease severity (uncontrolled on inhaled corticosteroids (ICS)). The basis for approval for mepolizumab was a reduction in asthma exacerbations, oral corticosteroid (OCS) sparing, and a positive trend towards improvement in asthma symptoms. If approved, reslizumab would be another choice in the class of anti-IL-5 agents. . . .

Recently approved mepolizumab also provides another option to OCS for patients with severe asthma and an eosinophilic phenotype. While reslizumab would similarly be an alternative to OCS, the proposed target patient population for reslizumab also includes a broader group of asthma patients with a lesser severity of asthma (i.e. those uncontrolled only on ICS) with evidence of eosinophilic inflammation, and therefore targets a broader patient population than that for whom mepolizumab is approved. . . .

Now you know. And now off to get a late lunch, while enjoying a sunny Monday afternooon here. . . Onward.

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