EMA Panel Rejects Omeros' Narsoplimab for TA-TMA in Europe

Event summary

CHMP issued a negative opinion on Omeros' marketing authorization application for narsoplimab in TA-TMA after re-examination.
An eight-member ad hoc expert group recommended a review of individual patient-level data by external experts.
Narsoplimab is FDA-approved in the U.S. as YARTEMLEA but lacks European approval.
Omeros plans to terminate the YARTEMLEA compassionate-use program due to increasing U.S. demand.

The big picture

The CHMP's rejection highlights the regulatory hurdles for niche therapies in Europe, contrasting with the FDA's broader approval. Omeros' ability to navigate these differences will be critical as it seeks to expand YARTEMLEA's global reach. The company's focus on its MASP-2 franchise and other pipeline candidates underscores its strategy to mitigate reliance on a single market.

What we're watching

Regulatory Strategy: Whether Omeros can secure patient-level data review to overturn the negative opinion.
Commercialization Shift: How the termination of the compassionate-use program impacts European patient access.
Pipeline Progress: The pace at which Omeros advances additional indications for its MASP-2 franchise.