Oral Peanut Allergy Tx OK'd

Andrew Cummings
February 4, 2020

The drug, Palforzia, will list for $890 a month and brings its own risks, the Wall Street Journal reports.

Another potential downside is that clinical studies with this and other immunotherapies for peanut allergy have indicated that therapy must continue indefinitely, as tolerance decreases once treatment stops. But it could bring long-sought relief to families that have had to build their lives around avoiding exposures.

The treatment, called AR101 and to be sold under the brand name Palforzia, was created to gradually reduce sensitivity to peanuts by exposing patients to a highly refined version of peanut flour over several months.

"When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy", Marks said.

"He continues to take Palforzia, which has given him more independence and his parents more peace of mind".

Treatment with this oral immunotherapy may be initiated in individuals ages 4 years to 17 years with a confirmed diagnosis of peanut allergy, and may be continued in individuals 4 years of age and older.

Some 1.6 million USA children aged 4 to 17 live with peanut allergies, Aimmune says, creating an opportunity for peak annual sales in excess of $US1 billion. The Initial Dose Escalation phase is given on a single day. Side effects were abdominal pain, vomiting, nausea, tingling in the mouth, itching, cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis (serious, life-threatening allergic reaction). The Up-Dosing phase consists of 11 increasing dose levels, and occurs over several months.

"Peanut allergy carries an overwhelming psychosocial burden that impacts patients and their families daily - peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates families' daily lives", said Lisa Gable, Chief Executive Officer of the Food Allergy Research and Education (FARE), in Aimmune's press release. The drug comes in powder form within pull-apart capsules that can be dumped into foods like pudding or applesauce for eased consumption.

Safety testing: Two double-blind, placebo-controlled studies700 people with peanut allergies in. The FDA requires patients to take their first dose and each increased dose under supervision in a certified health center, and doctors and their patients must enroll in a special safety program, the AP reported. The placebo group came in at 4%, while the Palforzia group came in at 67.2%.

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