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FDA Approves First Drug for Sinusitis With Nasal Polyps, Dupixent (Dupilumab)

THURSDAY, June 27, 2019 -- In what specialists say could be a turning point in care, the U.S. Food and Drug Administration on Wednesday approved the first drug to treat chronic sinusitis that involves the growth of polyps within the sinuses.

Dupixent (dupilumab) is given by injection every two weeks. It was approved to treat patients with nasal polyps and chronic rhinosinusitis -- defined as a prolonged inflammation of the sinuses and nasal cavity, the FDA said.

"Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps," explained the FDA's Dr. Sally Seymour in an agency news release.

"Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids," said Seymour. She directs the division of pulmonary, allergy and rheumatology products at the FDA's Center for Drug Evaluation and Research.

Specialists familiar with the chronic condition applauded the drug's approval.

"Otolaryngologists and allergists have been waiting years for this approval," said Dr. David Hiltzik, who directs head and neck surgery at Staten Island University Hospital in New York City.

"It adds a novel approach that has not been applied previously," he said, and "can potentially mark a shift to full medical [drug] treatment for a subset of patients that are severely impacted by their disease. For other patients, it adds another form of treatment in addition to steroids, antibiotics and surgery."

Dr. Jordan Josephson is an ear, nose and throat (ENT) and sinus specialist at Lenox Hill Hospital, also in New York City. He said that early studies suggest Dupixent is "very promising as another tool in the fight against chronic sinusitis and nasal polyps."

Josephson stressed that chronic rhinosinusitis with nasal polys can seriously impact quality of life. People with the condition often suffer "from symptoms including nasal congestion, loss of sense of smell, postnasal drip, cough, hoarseness, asthma, sinus headaches and/or snoring and sleep apnea," he said.

Many undergo drug treatment or surgery to help ease the condition but, if these fail, "Dupixent may offer just the solution," Josephson said.

According to the FDA, Dupixent, made by Regeneron Pharmaceuticals, was originally approved in 2017 for certain patients 12 and older with eczema. In 2018, Dupixent was also approved as an add-on maintenance treatment for certain patients 12 years and older with asthma.

The approval announced Wednesday was based on two studies of 724 patients, aged 18 and older. Patients who received the drug had statistically significant reductions in nasal polyp size and nasal congestion compared to those who received an inactive placebo, according to the FDA.

Patients who received Dupixent also reported improvements in their ability to smell, and they also required less nasal polyp surgery and oral steroid medications.

Drug side effects can occur, however. Dupixent may cause serious allergic reactions and eye problems, such as inflammation of the eye (conjunctivitis) and inflammation of the cornea (keratitis), the FDA said.

Patients who experience new or worsening eye symptoms -- such as redness, itching, pain or visual changes -- while taking Dupixent should contact their health care provider, the agency advised. Patients receiving Dupixent should also not get live vaccines.

Hiltzik wondered too about the new drug's price tag.

"A major drawback will be the cost of the medication and gaining access to all patients that will require this medication," he said.

Josephson also worried about the drug's cost, and he noted that not everyone may benefit equally.

"Sinus problems and nasal polyps are complex problems which will still require a good comprehensive treatment plan for most patients, which may or may not include Dupixent as part of the treatment," Josephson said.

More information

Harvard Health has more on nasal polyps.

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Posted: June 2019

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