FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal

The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites.

The hold blocks recruitment of new patients but permits treatment of participants already enrolled in two pivotal trials.

The action follows Biohaven’s recent licensing agreement with SK Biopharmaceuticals, which includes a $350 million upfront payment and additional milestone payments. Biohaven disclosed all pre‑clinical and clinical data, including metabolite information, before the deal was signed.

Biohaven noted that the metabolites, identified as opakalim, present an uncertain risk to humans, prompting the FDA’s precautionary step.