Novartis is staring at some serious problems rolling out its diabetes drug Galvus. New data showing patients taking higher doses of the drug--100 mg--demonstrated more frequent enzyme elevation levels prompted Novartis to seek a revision in prescribing recommendations before the drug is marketed in Europe. The company plans to recommend once or twice daily dosing of 50 mg. That move raised analysts' concerns that Galvus will be less competitive than expected against Merck's once daily Januvia [1]. Novartis had been planning to resubmit Galvus for U.S. approval in 2009. The FDA issued an approvable letter for Galvus earlier this year, outlining a request for additional information.
- see the release [2] from Novartis
- read the report [3] from in-Pharma Technologist
Related Articles:
Galvus delay raises questions about drug class. Report [4]
FDA expected to approve Januvia soon. Report [5]
FDA demands new trial for Galvus. Report [6]
Galvus review period extended. Report [7]
Novartis seeks European OK for Galvus. Report [8]
Links:
[1] http://www.fiercebiotech.com/tags/januvia
[2] http://www.fiercebiotech.com/press-releases/press-release-new-galvus-clinical-data-reinforces-efficacy-profile-safety-update-prov
[3] http://www.in-pharmatechnologist.com/news/ng.asp?n=81137-novartis-galvus-eucreas-diabetes-safety
[4] http://www.fiercebiotech.com/story/galvus-delay-raises-questions-about-drug-class/2007-03-01
[5] http://www.fiercebiotech.com/story/fda-expected-to-approve-januvia-soon/2006-10-16
[6] http://www.fiercebiotech.com/story/fda-demands-new-trial-for-galvus/2007-02-26
[7] http://www.fiercebiotech.com/story/spotlight-galvus-review-period-extended/2006-11-13
[8] http://www.fiercebiotech.com/story/novartis-seeks-european-ok-for-galvus/2006-08-17