Regeneron Pharmaceuticals’ (REGN.Q) Dupixent one step closer to providing relief to sufferers

09/20/2019

My best friend growing up married a woman with severe rhinosinusitis and nasal polyps. That sounds about as serious as a case of the common cold and a bad headache, but there were many lost nights where my friend and his wife required an ER visit to get her breathing again.

It didn’t happen often—maybe twice a year—but it was enough to leave a lingering psychological effect. Working night shifts for him carried an extra layer of dread, and visiting friends overnight left a nagging sense of worry to germinate in the back of the mind. Worries magnified. No matter how much they planned for the eventuality, it was never enough. The what ifs piled up. They had contingency plan on top of contingency.

Chronic rhinosinusitis with nasal polyps is a disease of the upper airway that blocks off the sinuses and nasal passages. The polyps are soft, painless and noncancerous growths on the lining of the sinuses that hang down like teardrops or grapes. They’re one of those vagaries of the genetic code, passed down from generation to generation like hair colour and freckles. Her polyps were big enough to require a small bag full of asthma inhalers, pills and other sleep aids. And so many surgeries.

In other folks, it leads to persistent breathing difficulties, nasal congestion and discharge, as well as a reduced or loss of sense of smell and taste, not to mention facial pressure and pain. Nearly 3.5 million Canadians suffer from acute rhinosinusitis every year, according to the National Institute for Biotechnology Information.

Regeneron Pharmaceuticals (REGN.Q) and Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended their product, Dupixent, be approved as an accompaniment therapy with intranasal corticosteroids for adults with this disease. Especially if the traditional therapy of systemic corticosteroids or surgery hasn’t helped the patient get control of the problem.

Regeneron is a biotechnology company that makes medicines for people with serious diseases, including cancer, eye diseases, allergic and inflammatory diseases, cardiovascular and metabolic diseases and worse. They’ve been around for 30 years, led by physician-scientists who have spun their superpower of consistently translating science into medicine into seven FDA-approved treatments and numerous product candidates in development.

The recommendation came on the tail end of successful trials that evaluated Dupixent 300 mg every two weeks, plus standard-of-care intranasal corticosteroids compared to placebo plus the same steroids.

Dupixent is a cloned antibody that blocks signals going to proteins. The clinical trials showed that the medicine effected the proteins responsible for the inflammation that leads to the growth of polyps, asthma and atopic dermatitis (or excema).

Basically, it would come as an injection into the nasal passage, and if it was fast acting enough, it would counteract the series of biochemical reactions that cause the creation and development of the proteins the grow the polyps.

Dupixent is already on the market for eczema and asthma that hasn’t responded to other prescription medications. It can be used with or without topical steroids, but it shouldn’t be used on children below 12 as effects are as yet unknown. For asthma, it’s mostly used for as a preventative, but not as a palliative for treating asthma attacks.

The Negatives of Dupixent

For people at the end of their tether, any promise of relief comes with a healthy dose of skepticism. What’s the price in both time, energy, and money? What’s the trade-off? What extra bullshit are we going to have to put up with?

And those aren’t easy questions.

These drugs often come with more potential problems so it’s always a risk/reward analysis issue. Mostly, though, if the risks involved are ‘not breathing’ versus things like ‘eye problems’ then not breathing wins every time. Hands down. You take the drug and you absorb the risk, because eye problems won’t kill you.

DUPIXENT can cause serious side effects, including:

  • Allergic reactions (hypersensitivity), including anaphylaxis. breathing problems, fever, general ill feeling, swollen lymph nodes, swelling of the face, mouth and tongue, hives, itching, fainting, dizziness, feeling lightheaded (low blood pressure), joint pain, or skin rash.
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, shortness of breath, persistent fever, chest pain, or a feeling of pins and needles or numbness of your arms or legs.

A final decision on the Dupixent application by the European Commission (EC) is expected in the coming months. For my friends and others suffering from this disease, hopefully it’s enough.

—Joseph Morton

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