🎯 Spotlight on Progress: We’re thrilled to see how real-world evidence (RWE) is transforming the landscape of drug and biologic approvals in rare diseases. According to a recent article from the American Society for Clinical Pharmacology & Therapeutics (ASCPT), between fiscal years 2020 and 2022, the US FDA approved five drugs and biologics where RWE played a pivotal role in demonstrating effectiveness for regulatory decisions. There has been tremendous progress since then:

🔹In 2020, only about 5–10% of FDA approvals involved RWE
🔹In 2023, the FDA approved over 100 applications for new indications, with RWE supporting a significant portion, especially in repurposing existing drugs
🔹By 2024, this proportion rose sharply, with 45–50% of approvals leveraging RWE as a supplementary or pivotal data source

At Clinakos, our Integrated Patient Data™ platform brings together clinical, genomic, and real-world data to accelerate rare disease and oncology research and drug development. By delivering a unified, comprehensive view of each patient, we empower life sciences and researchers to generate actionable insights—driving smarter decisions and meaningful breakthroughs for rare disease communities.

🚀 Let’s make every data point a step forward for rare disease patients—together. 🚀

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👇 Find the article here: https://lnkd.in/g-_X5yVb