Breakthrough for UCB as Xyzal Finally Approved by U.S. FDA

Xyzal Ready for U.S. Market Debut

Six years after going on sale in Europe, allergy drug Xyzal (levocetirizine dihydrochloride) has finally been granted regulatory approval to be marketed in the United States. The green light from the U.S. FDA means that Xyzal, produced by Belgian drug company UCB, will be ready to hit U.S. pharmacy shelves in time for the 2007 autumn allergy season. Xyzal has been on sale in Europe since 2001 and is currently approved in over 80 countries worldwide. The drug's approved U.S. indication covers the treatment of "symptoms associated with seasonal and perennial allergic rhinitis and treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children six years of age and older", according to UCB.

The significant gap between European and U.S. approval of Xyzal is not due to any dissatisfaction on the part of the FDA with the drug itself, but rather to UCB's long-running quest to secure a U.S. marketing partner. The Belgian company had originally hoped to co-market the drug with U.S. pharma giant Pfizer, which already acts as U.S. partner for Xyzal's predecessor drug, Zyrtec (cetirizine dihydrochloride), but eventually conceded that Pfizer was looking at other options in the allergy market and would not be on board for Xyzal (see United States: 16 March 2006: Pfizer Unlikely to Co-Market Xyzal in U.S.). UCB filed a New Drug Application (NDA) with the FDA in July 2006 regardless, and by September had convinced French pharma company Sanofi-Aventis to co-market the drug in the United States (see Belgium: 26 September 2006: UCB Finally Secures U.S. Marketing Partner for Xyzal as Sanofi-Aventis Steps Up to the Plate).

Zyrtec and Xyzal are UCB's second and third most important drugs by sales, bringing in respective global turnover of 561 million euro (US$755.2 million) and 143 million euro during 2006. However, while Xyzal's sales are expanding by double-digit levels—up by 13% year-on-year (y/y) in 2006—Zyrtec's growth in turnover has slowed to a crawl since having been genericised, inching up by just 2% y/y on a comparable basis over the same period.

Outlook and Implications

UCB and Sanofi-Aventis have stopped short of revealing whether they will urge U.S. doctors to automatically switch patient prescriptions from Zyrtec to Xyzal, and the new arrival will face strong competition from the many over-the-counter (OTC) allergy drugs that are already household names. Xyzal's steady sales growth in Europe and other markets bodes well for the product in the United States, however, and the drug has significant potential for an eventual switch from prescription-only to OTC status. The UCB hopeful does have several important safety considerations, though, including contraindications in patients with end-stage renal disease and paediatric patients with impaired renal function, as well as a general warning against "engaging in hazardous occupations requiring complete mental alertness and motor coordination" after taking Xyzal. In spite of this, the U.S. approval is the culmination of years of R&D work by UCB, which now stands to gain development and commercial milestone payments from Sanofi-Aventis once the drug is launched. This extra revenue will be welcome for UCB as it prepares for its impending takeover of Germany's Schwarz Pharma. The U.S. approval also takes some of the bad light off leading pipeline compound Cimzia (cetolizumab pegol), which is now facing a year-and-a-half delay before possible U.S. approval due to efficacy trials requested by the FDA (see Belgium: 23 March 2007: Further Delays for Cimzia Approval as UCB Announces New Efficacy Trial).