UCB gets EMEA approval for intravenous Keppra use

Biotech firm UCB has announced European approval for its epilepsy drug Keppra.

In a statement it said that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) had sent the company a positive opinion regarding the drug’s intravenous use. It now clears the way for the treatment to be marketed for sufferers of partial onset seizures.

UCB added that the US Food and Drug Administration (FDA) had sent an approvable letter outlining labelling and manufacturing concerns which required solving before it completed its review.

Keppra is already available for the treatment of partial onset seizures but in solution and tablet forms for adjunctive therapy, both in Europe and the US.

Roch Doliveux, CEO of UCB, was delighted with the news, claiming it to be an “important step in the continuing development of Keppra”. He said that the intravenous form would allow its use within emergency situations where oral treatment “is not an option”.

He added: “When approved by the regulatory authorities, Keppra will become the first of the newer antiepileptic drugs to be available in an intravenous formulation.”

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