Belgium's UCB gets first approval for antihistamine drug Xyzal, in Germany

Belgian drugs and chemicals group UCB has received approval from theGerman health authorities to market its new generation antihistamine Xyzal (levocetirizine). This is the first approval of the product anywhere in the world. The compound, which has been developed by UCB's R&D team under license from Sepracor of the USA, has patent protection until 2013, according to a company statement.

Xyzal is a single-isomer version of UCB's successful Zyrtec (cetirizine), which produced revenues for the company of some $300 million in 1999 and $331 million for the first six months of 2000 (compared with half-year group pharmaceutical turnover of 587 million euros ($556.7 million). In North America, Zyrtec is marketed with Pfizer. However, as far as levocetirizine is concerned, Sepracor has retained exclusive rights for the US and Japanese markets.

UCB says that the new drug, which will also be trade-named Xusal in some markets, has been submitted for approval in other countries either through the European Union mutual recognition procedure or through the direct submission procedures. In Germany, UCB points out, Xyzal/Xusal gained registration for all three relevant indications in its class, ie seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. It is expected to be introduced into its first market early-February, with further launches planned for the rest of Europe this year as respective regulatory approvals are received.