The FDA grants certain designations, such as the Orphan Drug (ODD) and Fast Track designations (FTD), to medications intended to treat rare and severe disorders. Recently, they granted both of these designations to Fasenra. The ODD is for eosinophilic gastroenteritis (EGE) and eosinophilic gastritis (EG), while the FTD is just for EG with or without EGE.
Orphan Drug and Fast Track Designations
These designations are intended to help the development of certain drugs. Starting with the ODD, it is reserved for medications that treat, diagnose, or prevent rare diseases. For this designation, a rare disease is defined as one that impacts fewer than 200,000 U.S. citizens. The FDA gives a number of incentives along with an ODD, such as fee exemptions, tax credits, and market exclusivity.
Turning to the Fast Track designation, it is meant to get important treatments to patients sooner, as it is reserved for medications intended to treat severe disorders with unmet medical needs. Like the ODD, it also brings a number of benefits. These include rolling review, accelerated approval, priority review, and more frequent communication with the FDA regarding development and approval.
Fasenra for EGE and EG
This monoclonal antibody binds to IL-5 receptor alpha on eosinophils, leading natural killer cells to induce programmed cell death. It has already received approval as an add-on therapy for eosinophilic asthma in a number of countries and is still being developed to treat other eosinophilic disorders.
Eosinophilic gastroenteritis (EGE) is a form of eosinophilic enteropathy that impacts the stomach and small intestine. Due to the accumulation of eosinophils within these organs, polyps begin to develop, tissue breaks down and becomes inflamed, and ulcers form. This causes symptoms like:
- Skin rash
- Loss of appetite
- Stomach cramps
- Acid reflux
- Blood in the stool
While medical professionals know that a buildup of eosinophils leads to these symptoms, they do not know what causes this accumulation. Evidence suggests that family history and hypersensitivity to certain triggers could play a role.
Like EGE, eosinophilic gastritis (EG) occurs when eosinophils accumulate in the stomach, causing irritation and injury. This leads to symptoms like nausea, fatigue, vomiting, stomach pain, trouble with weight gain, poor growth, anemia, trouble eating, and weight loss. Similar to EGE, medical professionals are unsure as to what exactly causes this condition.
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