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First Drug for Peanut Allergy Nears FDA Approval

Introduction to peanut allergy:

Peanut allergy is an allergic condition of the body in which the immune system of the body identifies the minute amount of peanut as a harmful foreign object, mistakenly. These reactions are unpredictable in nature as they can present and occur unpredictably, varying in intensity of their nature. Some individuals can even have a severe intensity of reactions just by a trace amount of peanut in the body.

Peanut Allergy
Source:Global News

Sign and symptoms of peanut allergy:

Physical symptoms of peanut allergies can occur immediately after exposure to peanuts.

These symptoms include:

  • Skin reactions like swelling, redness, and hives.
  • The discomfort of the digestive system.
  • More dangerous and fatal reactions.
  • Several conditions of airways and throat.
  • Loss of blood flow in the normal amount to vital organs inside the body.

Incidence of peanut allergy:

Peanut allergy is found to be affecting about one million children approximately in the US, and only one out of five children can outgrow this allergy in the lifetime.

The reason for the severity of this allergy is that there is not any cure for it, and individuals suffering from this allergy are strictly advised to avoid the peanuts; otherwise, it can end up into life-threatening and dangerous reactions.

The researchers say that even following the strict avoidance from peanuts, one can unintentionally or accidentally get exposed to peanuts.

A new gene therapy strategy, courtesy of nature. Scientists turn a natural cellular process into a drug delivery system

First-ever drug for peanut allergies:

Recently, the FDA (Food and Drug Administration) approved a drug known as Palforzia to fight the allergic reactions caused by peanuts, which may occur after the physical exposure to peanut or peanut products. The treatment of this drug can be given to individuals ranging in ages between 4 years to 17 years, having a diagnosis of allergy from peanuts.

Individuals undergoing peanut allergy treatment with this drug must avoid intake of peanuts in their diet during the treatment phase.

If this drug is used in conjunction with avoidance from peanuts, then according to FDA, Palforzia can be given as an available treatment option for reducing the risk of allergic reactions associated with peanuts among children.

Palforzia
Source: Medpage

How does treatment occur?

The treatment with this drug occurs in the three main phases.

  1. Initial escalation of the dose.
  2. Up-dosing phase.
  3. Maintenance phase.

Phase-one is given only on a single day.

Phase-two consists of 11 levels of doses, which occurs over several months. The phase one and phase two are performed under the strict supervision of health care providers or under some health care facility, which is capable of coping with any emergency allergic reaction inclusive of anaphylaxis.

As the anaphylaxis can occur unpredictably at any time of the day during the treatment with this drug, therefore, patients are usually at high risk during the treatment after the initial escalation of dose and up-dosing levels.

During the second phase, if a patient is capable of tolerating the first dose, then the patient can be advised to continue the same dose levels at home, daily. Once the patient has completed all the levels of up-dosing, then he or she can maintain that dose for the rest of the treatment. Patients who are suffering from specific reactions on account of Palforzia should discontinue the use of this drug and modify their schedule of dosing.

How to consume this drug?

Palforzia is in a powdered form that is manufactured with peanuts and packaged in a capsule form for phase-one and phase-two use, while for phase-three, it is available in sachet form.

This powder can be emptied form packed capsules or from the sachets, which is mixed with some semi-solid food like pudding, yogurt, or applesauce. Then the patient is asked to consume it.

How effective is this drug?

In order to find the effectiveness of this drug, a double-blind and placebo-controlled trial was conducted, enrolling 500 patients suffering from peanut allergy in Europe, Canada, and the US. The effectiveness was evaluated by the participants of the study who were successfully tolerating the 600mg dose of this peanut protein (two times a day, maintenance with Palforzia), leading to no more symptoms of allergy after going through six months of treatment. The results of the study showed that about 67.2 percent of the population successfully tolerated 600 mg dose in the challenge, while 4.0 percent population was receiving the placebo treatment.

Safety of the drug:

For the safety assessment of Palforzia, two double-blinded and placebo-controlled studies were conducted enrolling about 700 patients suffering from a peanut allergy. The most prominent side-effects associated with this drug were anaphylaxis, difficulty breathing or shortness of breath, hives, wheezing, tingling sensation in the mouth, abdominal pain, nausea, vomiting, and itching. It is not advised to give this drug to patients suffering from uncontrolled episodes of asthma.

FDA Approved Drug
Source: Yahoo

FDA’s guidelines for the drug:

To cope with the risks associated with this drug, the FDA has issued REMS (Risk Evaluation and Mitigation Strategy) for its approval which ensures that:

  • This drug will only be available through specialized and certified health practitioners, pharmacies, health care facilities to patients who are already enrolled in this program.
  • Practitioners and other healthcare facilities that are practicing this drug for treatment should be well-educated about the risks of anaphylaxis related to this drug.
  • The phase one and two must be carried out in any health care facility, which should be equipped with all the equipment to monitor the patients for earlier identification and management of anaphylaxis.
  • Patients or their caregivers should always be counseled for the need of their patients to get epinephrine injected, in need of immediate use.
  • They should know how to avoid the use of peanuts and how to accurately recognize the signs and symptoms associated with anaphylaxis of drugs.

Aimmune therapeutic has gained approval of Palforzia from FDA.

Summary:

Peanut allergy is the most dangerous and fatal allergy associated with peanut consumption. There isn’t any proper treatment for this allergy. FDA has approved its first-ever drug for treatment but with specific guidelines to avoid its side-effects and anaphylaxis.