New FDA Approval: Cinqair

New FDA Approval: Cinqair

Drug

Reslizumab [Cinqair]

Indication

It's yet another monoclonal antibody (YAMA? #YAMA?) approved for the treatment of severe asthma that is poorly controlled.

Another -mab?

We are only beginning to see a burgeoning market for -mabs. If you're not quite up to snuff on how they work and what they do, check out our post.

How it Works

Reslizumab is a humanized monoclonal antibody that targets interleukin-5 (IL-5), which plays a role in eosinophil production and activation. Blocking IL-5 means less eosinophils that can cause inflammation and asthma exacerbation. Basically, reslizumab gives IL-5 the kind of hug that only your overly doting aunt can give. The kind that lingers way too long and feels like it will never end. Resilizumab holds IL-5 and never lets go (unlike Rose). And, just like you when you're in the grips of a death-hug by your aunt....IL-5 can't do jack when reslizumab is around.

Left alone, IL-5 would basically run through the halls of high school banging on doors like the last day before summer break.

Notable Adverse Effects

So this is one of the few times that I like to point at the FDA Press Announcement, because this little tidbit is golden:

"Cinqair can cause serious side effects including allergic (hypersensitivity) reactions. These reactions can be life-threatening. The most common side effects in clinical trials for Cinqair included anaphylaxis, cancer, and muscle pain."

That's right: cancer. Word is mum so far on the type of cancer, though it's common to see some form of lymphoma show up as a result of immune suppression. Also IL-5 and bladder cancer may be linked. Regardless, the main risk is anaphylaxis, which isn't surprising given that it is a monoclonal antibody. Thus, the medication is administered every 4 weeks by infusion while being monitored.

Current Place in Therapy

So, you might wonder what kind of person would sit in a chair to get an infusion once a month. Well, when you can't breathe you'll do just about anything. And this isn't the first -mab to be used for asthma (see: omalizumab [Xolair]). Or even the first -mab used for asthma with this mechanism (see: mepolizumab [Nucala]).

This post isn't a review on asthma management. But there is some not very tldr-y guideline stuff from the National Heart, Lung, and Blood Institute on the management of asthma. For now, you'll probably just want to know that omalizumab is reserved for the severest of asthma. And mepolizumab and reslizumab aren't even listed in the guidelines yet. But they will probably be reserved for the same severe asthma cases (steps 5 and 6).

More -mabs?

As we mentioned in our -mab tutorial, -mabs are the future. They're targeted therapies that have fuzzy patent laws which allow dollars to be made. And some of them are truly revolutionary in terms of how they're impacting drug therapy. Either way, the point is that you'll be seeing many more of them. 

On the horizon right now is another IL-5 directed antibody (benralizumab), which has a very interesting saga of it's own (didn't improve COPD exacerbation, now being marketed in Japan). So stay tuned...

Absolute Risk Reduction: Your Secret Weapon in Literature Evaluation

Absolute Risk Reduction: Your Secret Weapon in Literature Evaluation

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