Sobi's high-priority rare disease drug runs into a wall at EMA
The EMA has rebuffed Sweden-based Sobi’s pitch for emapalumab, shooting down high hopes for a $568 million drug.
Sobi said it will request a re-examination by the regulators, which will kick off a new review process that should produce a decision by the end of the year. The antibody is designed to treat primary hemophagocytic lymphohistiocytosis in children under 18 years old by targeting interferon gamma (IFNγ).
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