HLB exempted from submitting rivoceranib pediatric clinical plan in Europe

The European Medicines Agency (EMA) has exempted HLB from submitting a pediatric investigational protocol (PIP) for its liver cancer drug candidate, rivoceranib. This will help accelerate the company's entry into Europe.

HLB said Thursday that its U.S. subsidiary, Elevar Therapeutics, has received notification from the EMA that it has been granted a PIP exemption for rivoceranib. PIP is a regulatory requirement introduced by the EMA to demonstrate that a drug is safe and effective in pediatric patients during development.

Normally, a PIP is required before approving a drug but can be omitted if:

● The disease does not occur in children.

● The drug is deemed unsafe or ineffective when used in pediatric patients.

● The study is not feasible in children due to technical limitations.

HLB emphasized that the PIP submission exemption provides significant time and cost benefits, given the six months or more required to prepare a PIP protocol.

HLB is awaiting the U.S. Food and Drug Administration’s marketing authorization review for rivoceranib plus chemotherapy for liver cancer and plans to file for new drug applications in Europe, Korea, and Asia following the U.S. approval. The FDA's review deadline is May 16.

Elevar signed an agreement with a European pharmaceutical company late last year to provide regulatory consulting for the EMA's new drug application. If successful, HLB plans to commercialize rivoceranib directly in the U.S. and jointly through European partnerships.

"With the U.S. new drug approval in sight, we are focusing on the next step, the European filing process," said Han Yong-hae, CTO of the HLB Group. "A new drug approval in the U.S., along with successive approvals in other parts of the world, will be a strong signal for rapid expansion into multiple other indications."