Summary
Merck and the FDA are working to revise the prescription guidelines for Januvia to reflect incidences of pancreatitis seen in association with Januvia. Also, post-hoc analysis presented at EASD showed that those completing two years of Januvia monotherapy had A1c drops from 8.4% to 6.9%. Lastly, Januvia therapy as an adjunct to insulin therapy received approval by the EMEA, making it likely to be adopted by the European Commission for this indication.
Analysis
We see the A1c results as extremely positive and think the EMEA step is an important move forward, but note the small number of patients (n=32) who completed the Januvia monotherapy regimen-- the rest had to go on more aggressive rescue therapy with Januvia and another compound. We are also cognizant of the impact of a pancreatitis risk both on patient health and Januvia's market, however, it is not clear whether the 88 pancreatitis cases observed between 2006 and 2009 were associations or causations. Global estimates for the Januvia franchise in 2009 are $2.4 billion to $2.7 billion. It has been approved in over 80 countries and 15 million prescriptions have been written.
Kelly Close consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
