A panel of external consultants recommended that the Food and Drug Administration provide an insight into a proposed treatment for peanut allergies in children, a step which could clarify the way in which the first approved treatment of the condition could be marketed.
This drug, AR101 is called code, is made of peanut flour and is given as a powder mixed with foods. A developer,
He recommends marketing it under the Palforzia brand.
The FDA is not required to follow the advice of its advisory committees, but it usually does so. It is estimated that by the end of January, the agency will determine an application to ammunize the drug in the United States.
Trading in Aimmune shares was stopped during Friday's regular hours due to the advisory committee meeting. After hours, the stock got 16% to $ 28.72. Prior to Friday it had increased by 3.1% this year.
said that allergy patients and their families are “eagerly waiting for a FDA-approved medicine that will give them a choice that they cannot avoid alone.” t
Peanut allergies have emerged as a life-threatening hazard for many parents, requiring them to marke ingredients over any signs of groundnuts and to give devices to their children – and to schools – to help allergic reactions sudden and unexpected.
The incidence of peanut allergies in children has increased by 21% since 2010, according to Allergy College, Asthma and American Immunology. Almost 2.5% of children in the United States may have a peanut allergy.
However, there is no approved medicine that can prevent allergy attacks. Instead, doctors have advised for years that children avoid whole peanuts, not an easy task. And those with allergies carry epinephrine shots in case of casualty exposure.
In recent years research has been expected in preventive treatment. The study has shown that small amounts of foods containing peanuts could gradually introduce children to the severity of allergic reactions to prevent or limit. This approach is called oral immunotherapy.
The drug builds Aimmune, de Brisbane, Calif., On that concept. A study released last year found that the treatment helped with the incidence and severity of allergic reactions when children ingested a small amount of peanuts, compared to placebo.
The drug did not work for everyone and had a number of side effects, including allergic reactions to the drug itself. The FDA stated that it intended to include safeguards if it allowed the drug, as a requirement for patients to have cattle to treat allergic reactions.
The FDA advisory committee voted 7-2 that was supported for use in children aged between 4 and 17 years of age.
Some parents and children with peanut allergies have given evidence in favor of the drug at the hearing of the advisory committee in Silver Spring, Md., Including some said Aimmune for their travel.
A number of members of the committee expressed concerns about the allergic reactions to the drug, as well as a lack of racial diversity in the clinical study, most of which were white.
Write Peter Loftus at firstname.lastname@example.org
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