Mar. 21 at 10:37 AM
$OMER MedDRA is defined as a clinically validated international medical terminology used for regulatory activities in biopharmaceuticals, facilitating the classification of adverse events, including signs, symptoms, diseases, and procedures for data entry and reporting.
New PT in 29.0. valid as of March 1st
10092857 Transplant associated thrombotic microangiopathy
ema.europa.eu/en/documents/...
Why is this noteworthy?
Narsoplimab fits the classic EMA conditional approval profile:
✔ Serious, life-threatening rare disease
✔ No approved alternatives
✔ Strong efficacy signal
❗ But limited, non-randomized data
Conditional Marketing Authorisation (CMA) from the EMA allows faster access to medicines for unmet medical needs where benefits outweigh risks, despite incomplete data. These one-year renewable approvals require companies to conduct post-approval studies to confirm safety, including specific adverse event monitoring and mitigation.
Now, who proposed the new coding?
