Approval for Bristol-Myers Squibb
Yesterday, Europe's Committee for Medicinal Products for Human Use (CHMP) gave its positive recommendation for Onglyza. Now the companies just need to wait the couple of months for the European Commission to put its stamp of approval on the marketing application -- then marketing of the drug can begin.
In the U.S., an approval is a little less certain, but seems likely. The drug clearly works, but the Food and Drug Administration has become more strict about heart issues for diabetes drugs in the wake of GlaxoSmithKline's
As we get closer to the drug getting on the market, the question is how well Onglyza will be able to compete in a crowded diabetes market. The drug is taken orally, so it's got that going for it over Eli Lilly
On the other hand, Merck expects products containing Januvia to bring in $2.4 billion to $2.7 billion this year, so even a sliver of the me-too pie would be an OK addition.
Have another slice of Foolishness: