This page shows the latest alogliptin news and features for those working in and with pharma, biotech and healthcare.
Those concerns have caused warnings to be imposed on some rival drugs, namely AstraZeneca's Onglyza (saxagliptin) and Takeda's Nesina (alogliptin).
The FDA turned down Qtern with a request for more data 16 months ago, shortly before insisting on new labelling for saxagliptin and Takeda's rival DPP4 inhibitor Nesina (alogliptin) warning
Since then however, Onglyza and certain other DPP4 inhibitors such as Takeda's Nesina (alogliptin) have been hit by a series of safety warnings from the FDA, including an increased risk
Earlier this year FDA advisers recommended two DPP-4 inhibitors, AstraZeneca's Onglyza (saxagliptin) and Takeda's Nesina (alogliptin), should have their labelling updated to indicate a link to heart failure.
In April, an FDA advisory committee voted that labelling for AZ's Onglyza (saxagliptin) and Takeda's Nesina (alogliptin) should be amended to reflect an increase in the risk of hospitalisation
death. Importantly, the study was designed to specifically look at hospitalisations due to heart failure, which emerged as the safety signal for AZ's Onglyza (saxagliptin) and Takeda's Nesina (alogliptin),
More from news
Approximately 2 fully matching, plus 24 partially matching documents found.
Perhaps the surprise of the market is the growth of Vipidia (alogliptin) - a late 5th entrant DPP4.
NDA submission is planned by third quarter of 2014. Forest plans to sell Furiex's royalty rights to alogliptin and Priligy on to Royalty Pharma for about $415m.
More from intelligence
Approximately 0 fully matching, plus 2 partially matching documents found.
Health Unlimited is a global health consultancy and communications agency built by specialists with unmatched experience, perspective and expertise. For...