We're now down to one more week in 2009, and nothing recently to indicate that the FDA will suddenly surprise us with a long-awaited decision on the approvability of Victoza. Will it be a non-approvable letter? Approvable letter? It seems very unlikely considering the delays that the FDA will overrule its Advisory Committee and approve the product without further conditions be imposed on Novo-Nordisk, so if anything, the best that might be hoped for would be a demand from the FDA for more studies before approving the drug.

Is it the end of the road for Victoza in the US? Probably, as there is now a once-weekly formulation of exenatide undergoing FDA scrutiny, and other companies are also working on once-weekly versions of GLP-1 receptor agonists, thereby making Victoza not only a me-too drug with heavy safety baggage, but a drug that seems likely to be out-classed on its one potential claim to fame (that it needs be injected only once daily).

(In the meantime, European health authorities approved Victoza for sale in Europe in July 2009. Again, as is the situation with Galvus, Novo-Nordisk is making back some of its investment in the development of the liraglutide molecule, but nowheres near the level of profits that they would have been making if it had been rapidly approved in the USA.)

There's one final point to be made in this tale of two drugs. The end of the road in the US for these two drugs seems likely because of very appropriate caution by the often-maligned FDA. Regulators in other countries had access to the very same data that the FDA is concerned about, and those other regulators took a chance, and approved these drugs to be put on the market in their countries. But US citizens should take comfort that the FDA is closely scrutinizing the data, and doing its best to provide detailed look at the data and its potential implications for safety (versus the potential need for these two additional drugs). To which I say we owe a big thank you to the FDA.