Belgium’s UCB said yesterday that the intravenous formulation of its epilepsy drug Keppra moved closer to approval on both sides of the Atlantic.
Keppra (levetiracetam) was recommended for approval by the European Union’s Committee for Medicinal Products for Human Use (CHMP) for use as an intravenous administration and for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children aged over four.
Meanwhile, UCB also received an ‘approvable’ letter from the US Food and Drug Administration (FDA) for the same 100 mg/mL injectable dose of the drug used as adjunctive therapy in the treatment of partial onset seizures in adult patients with epilepsy.
Crucially, the approvable letter did not ask for any additional clinical data, but requested revised product labelling as well as some additional information regarding manufacturing. UCB has already submitted the requested information to the FDA, so the delay before approval will be short.
Keppra is already approved in tablet and oral solution formulations, but the intravenous version will extend use of the product into emergency seizure situations, where oral treatment is not an option, said UCB.
Keppra is a key growth product for the Belgian company, and the approval of the intravenous formulation is expected to drive the product in 2006 along with an extension of its indications to include primary generalised myoclonic seizures.
The drug has assumed even greater importance for UCB as it stands to lose patent protection on blockbuster allergy drug Zyrtec (cetirizine) in the USA in December 2007, and a follow-up product Xyzal (levocetirizine), failed to show a significant benefit in a trial looking at its role in asthma prevention.
With competition in the allergy sector fierce, UCB was hoping for the asthma indication to boost the take-up of Xyzal ahead of the inevitable drop-off in Zyrtec revenues after generic competition starts in the USA. Its other great hope is Cimzia (certolizumab pegol), an anti-tumor necrosis factor (TNF) alpha antibody that is due to be filed later this quarter as a treatment for Crohn’s disease.
