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FDA OKs 1st Drug for Sinusitis With Nasal Polyps

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In what specialists say could be a rotating point in care, the U.S. Food and Drug Administration on Wednesday approved the first medicine to treat chronic sinusitis that involves the increase of polyps within the sinuses.

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

“Nasal polyps can lead to loss of smell and often patients necessitate 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 situation commended 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 come near that has not been practical previously,” he said, and “can potentially mark a shift to full medical [drug] treatment for a separation of patients that are severely impacted by their illness. For other patients, it adds a different 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 support 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 established an inactive placebo, according to the FDA.

Patients who received Dupixent also reported improvements in their ability to smell, and they also necessary 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 concerned about the drug’s cost, and he renowned that not everyone may advantage evenly.

“Sinus problems and nasal polyps are multifaceted problems which will still require a good comprehensive treatment plan for most patients, which may or may not comprise Dupixent as part of the treatment,” Josephson said.
Ariana Grande Postpones Shows Due to Tomato Allergy
Pop singer Ariana Grande delayed two shows in Florida this week due to a tomato allergy.

“Tampa and Orlando, I woke up incredibly sick today, ran to the doctor here and have been told to postpone these shows tonight and tomorrow,” Grande, 25, wrote in an Instagram post Tuesday afternoon, People reported. “I’m so beyond devastated.”

On Wednesday, she said her illness was really a tomato allergy.”Update: we discovered .. that .. i had an unfortunate allergic response to tomatoes and my throat pretty much closed. still feels like i’m swallowing a cactus but slowly making progress! thank u all for your love and understanding. can’t wait to get back to performing and to make it up to Tampa and Orlando in November.”
Frustration Mounts as EpiPen Shortage Hits 1 Year
The continuing EpiPen shortage has hit the 1-year mark with no end in sight, leaving many families angry, confused, and harassed to get the epinephrine they rely on to discontinue life-threatening food allergies.

“This unexplained/under-explained shortage is ridiculous,” says Cassie Hart of Normal, IL, the mother of a child with a food allergy.

“We didn’t expect it to go this long,” says Todd Mahr, MD, a Wisconsin-based allergist and the parent of a child with food allergies. “And that’s frustrating to us and our patients.”

EpiPens are just one brand of an auto-injection device that delivers set doses of epinephrine, a medicine that can help stop severe, sometimes deadly, allergic reactions. But the EpiPen has long been one of the most popular and well-known auto-injector choices, in part because it’s widely accepted at schools since it’s the standard most teachers and staff are trained on.

“Schools and other support networks are typically only familiar with one auto-injector: EpiPen,” says Erin Malawer, a parent of a child with food allergies who also has an award-winning blog on the subject called Allergy Shmallergy. “We have a whole hold up system of teachers, administrators, etc., who are not trained on other epinephrine auto-injectors and even less contented administering epinephrine when it’s so critically wanted.”

That’s obtainable a lot of challenges for families in light of the provide scarcity of EpiPens and EpiPen Jrs, which dates back to May 2018 and may not end any time soon.

“Despite our significant efforts, we do anticipate further supply shortages over the coming months,” says Steve Danehy, director of media relations at Pfizer.Mylan, which distributes and sells EpiPens, says problems are linked to a subsidiary of Pfizer — Meridian Medical Technologies, which makes the devices. Danehy said in an email that the company is committed to resolving the shortage as quickly as possible, but he made it clear there is no timetable for it to end.

In fact, it could get inferior before it gets improved. Shortages are predictable to result in tighter supplies. This could continue through the summer as peak refill season comes as parents prepare for a new school year. That’s when children are necessary to bring extra auto-injectors to their classrooms or school offices and clinics.

“This is a big deal,” Malawer says. “People are aggravated, calling all over their cities, receiving on waiting lists at pharmacies. Families are worried about using their auto-injectors for fear that they might not be able to return them. That’s a dangerous thought.”

What We Know About the Shortage
So why has the scarcity lasted so long? The FDA’s website lists the cause as “developed delays.”

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