Every year, the FDA approves a number of new medications and vaccines. Some are first-in-class therapies, and others build on existing medications to address new unmet medical needs. Several of the drugs that have received approval this year are expected to make a significant impact in treating serious conditions. Journavx (suzetrigine), Blujepa (gepotidacin), and Yeztugo (lenacapavir) are just three examples.
To get a drug approved, researchers must submit an Investigational New Drug (IND) application to the FDA. The IND includes all of the drug information, including nonclinical safety data and a plan for testing the medication in humans. The FDA reviews the IND and makes a decision on whether to approve or reject it.
Once the drug is approved, the FDA will approve any label expansions that are submitted to it. This allows the medicine to be prescribed for additional diseases. If the drug has a high probability of helping patients, the FDA may also allow it to be sold directly to consumers through an accelerated approval process called Priority Review.
Despite the FDA’s focus on speeding up the drug approval process, it has been struggling with a lack of resources. Cuts to support staff and earlier voluntary buyouts have affected the team that reviews new medicines, leading to delays in reviewing applications and missing deadlines, STAT reports. This could have long-term impacts on the agency’s ability to approve medications. It’s also likely to affect how companies sponsor their drug candidates. Rather than investing in a years-long clinical trial just to get FDA approval, they may decide to move forward with treatments outside the US instead.