Watch out, Januvia. AstraZeneca and Bristol-Myers Squibb finally won FDA approval for their diabetes drug Onglyza, a DPP-4 inhibitor that will directly compete with Merck's fast-growing treatment. And there's no doubt that the drugmakers aim for Onglyza to steal Januvia market share: They're pricing the new drug right on par with it, at about $5.72 per pill.
An AstraZeneca spokesperson told Reuters that the wholesale price for both the 2.5 mg and 5 mg doses will come in at $5.72. That's comparable with Januvia's price, and the language on both drugs' labels is similar, too. Januvia's label is "marginally less cautious" on its use with other drugs, UBS analyst Gbola Amusa told the news service, but Onglyza is a smaller pill--thus easier to swallow--and is also expected to debut as a once-daily combo with the ubiquitous diabetes drug metformin. Merck's metformin combo Janumet is twice daily.
The upshot? As the first market entrant, Januvia is expected to continue in pole position, though Onglyza might slow its growth, Reuters said. Onglyza is expected to bring in $60 million this year, and $450 million by 2011, gaining blockbuster status eventually, analysts said. There's expected to be plenty of room for growth in the DPP-4 market, with predictions of $7 billion in global sales by 2015.
True to FDA's increased scrutiny of diabetes meds these days, however, AstraZeneca and Bristol-Myers are on the hook for a post-market study designed to look at the risk of cardiovascular side effects in high-risk patients. In the eight trials submitted to FDA, Onglyza didn't show an increased risk, but that was among patients who were mainly at low risk already.