Pharmacy Practice NewsOrphan Drugs Continue to Dominate Specialty Pipeline

According to Aimee Tharaldson, PharmD, a senior clinical pharmacist who spoke at the AMCP Nexus 2022 meeting, specialty medications continue to lead FDA approvals, with nearly half being developed for rare diseases. In 2023, many candidates will seek an orphan drug indication, which is a special FDA designation that provides tax credits for qualified clinical trials, exemption from user fees, and up to seven years of market exclusivity after approval. An estimated 7,000 orphan diseases exist.