Loading...

Good News: FDA Committee Approves Peanut Allergy Treatment; Bad News: It’s $10,000

A new treatment for people with severe peanut allergies just became one step closer to becoming available.

Last week,  an advisory committee of the U.S. Food and Drug Administration voted 7-2 to approve Palforzia, a standardized peanut powder product, to help reduce allergic reactions to peanuts for patients ages 4 to 17 as part of oral immunotherapy protocol.

Pharmaceutical company Aimmune Therapeutics developed the treatment.

An estimated 2.2% children in the U.S. are allergic to peanuts and while pills via oral immunotherapy don’t cure these allergies, they do make the symptoms more manageable.

The therapy involves gradual incremental daily exposure to tiny amounts of peanut powder which over the course of several months, has been shown to reduce the incidence and severity of allergic reactions to small amounts of peanuts in many patients.

Palforzia is essentially a standardized, medical-grade version of the treatment some doctors already offer using peanut flour.

The drug is controversial because research shows that some patients have a tripling of the risk (9.4% compared with 3.8% for placebo) of anaphylactic reaction during the time a patient is building tolerance to reach maintenance dose, and  some members of the Allergenic Products Advisory Committee expressed concern that the data omitted the outcomes of many patients who had dropped out of the trial because of adverse effects.

“To be consistent with your primary analysis, where people who don’t make it are considered failures, I think to be consistent, you can’t censor them. I think this might be a bit misleading,” said Erica Brittain, mathematical statistician and deputy branch chief at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Md.

Another concern is treatment can be costly, from $5,000 to $10,000 for the first six months of treatment to cost $5,000 to $10,000 and $300 to $400 a month after that.

 

 

You might also like

Batman138 Bro138 Dolar138 Gas138 Gudang138 Hoki99 Ligaciputra Panen77 Zeus138 Kilat77 Planet88 Gaspol168 Sikat88 Rupiah138 Garuda138 Gacor77 Roma77 Sensa138 Panen138 Slot138 Gaco88 Elanggame Candy99 Cair77 Max7 Best188 Space77 Sky77 Luxury777 Maxwin138 Bosswin168 Cocol88 Slot5000 Babe138 Luxury138 Jet77 Bonanza138 Bos88 Aquaslot Taktik88 Lord88 Indobet Slot69 Paus138 Tiktok88 Panengg Bingo4d Stars77 77dragon Warung168 Receh88 Online138 Tambang88 Asia77 Klik4d Bdslot88 Gajah138 Bigwin138 Markas138 Yuk69 Emas168 Key4d Harta138  Gopek178 Imbaslot Imbajp Deluna4d Luxury333 Pentaslot Luxury111 Cair77 Gboslot Pandora188 Olxtoto Slotvip Eslot Kuy138 Imbagacor Bimabet