Working toward an FDA-approved treatment for food allergies
To gain approval from the U.S. Food and Drug Administration (FDA) and earn the right to market a therapy to treat a medical condition, drug companies must complete successful clinical trials that establish safety, efficacy, and appropriate dose.
The FDA Development and Approval Process
Attaining regulatory approval for a product candidate is a rigorous, lengthy process that typically takes several years and requires significant investment. For drugs to treat serious conditions, the FDA has established official designations that support faster development and review. Aimmune’s AR101 treatment for peanut allergy has FDA Fast Track Designation status and Breakthrough Therapy Designation status for its potential to treat a serious condition and fill an unmet medical need.
To begin a clinical trial, a company submits an investigational new drug application (IND), which includes information on the drug’s composition, manufacturing, and previous data, often collected in preclinical studies. If the FDA determines that the data are sufficient and that the trial design includes informed consents and adequate protections from risk of harm, the company may begin to study the drug in humans in clinical trials.
Clinical trials are classified into four consecutive phases, each of which demands complete and significant data. After completing the first three phases, a company may seek approval of the drug from the FDA. The fourth phase takes place after approval.
- Phase 1 tests a drug for the first time in a small group of people to evaluate safety
- Phase 2 studies a drug in a larger group of people to determine effectiveness and further evaluate safety
- Phase 3 looks at the drug in an even larger group to confirm efficacy, monitor any side effects, and compare it with other treatments
- Phase 4, which takes place after FDA approval, tracks a drug’s safety and seeks more information about its risks, benefits and optimal use