On Friday, the U.S. Food and Drug Administration announced its approval of Palforzia, a new drug that aims to alleviate allergic reactions brought on by exposure to peanuts. The drug, Palforzia, will list for $890 a month and brings its own risks, the Wall Street Journal reports.
Scientists have found a treatment for peanut allergies in children (stock). But it could bring long-sought relief to families that have had to build their lives around avoiding exposures. Though patients will still be encouraged to avoid any exposure to peanuts, the drug will be an added measure to help children in the case of accidental contact with peanuts.
The treatment can cause side effects, possibly serious reactions.
Since the drug doesn't eliminate the chances of suffer anaphylaxis, in order to receive the treatment, parents, caregivers and patients should still have injectable epinephrine on their person at all times.
Some 1.6 million United States children aged 4 to 17 live with peanut allergies, Aimmune says, creating an opportunity for peak annual sales in excess of $US1 billion. Aimmune Therapeutics' medication can not be used for the emergency treatment of allergic reactions, including anaphylaxis.
Doses: Daily during the Maintenance phase, which is the third phase.
The FDA-approved peanut allergen powder is manufactured from peanuts and packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing, and in a sachet for maintenance treatment. They must then continue taking a daily dose to be able to tolerate accidental exposure. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food-such as applesauce, yogurt, or pudding-for consumption.
The effectiveness of the oral immunotherapy is supported by a randomized, double-blind, placebo-controlled study conducted in the US, Canada and Europe in approximately 500 peanut-allergic individuals.
The drug AR101, or Palforzia, uses oral immunotherapy, with children given tiny but increasing amounts of peanut protein over a six-month period under medical supervision.
The safety of the medication was assessed in 2 double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals. The placebo group came in at 4%, while the Palforzia group came in at 67.2%. This therapy should not be administered to those with uncontrolled asthma.
Because of the complexity of introducing an allergen to an allergic individual, even as a treatment, the FDA says that Palforzia will only be available through specially certified health-care providers who are enrolled in the Risk Evaluation and Mitigation Strategy program.