A competition to grab market of long acting diabetes medication is likely to occur if FDA approves extended version of Exenatide. Exenatide is generic for Bytta. Extended Exenatide is known as Bydureon. FDA has already issued response letter for extended exenatide.
Bydureon is brand name of extended exenatide. The earlier short acting version Bytta (brand name for exenatide) was approved in 2005 for treatment of Type 2 diabetes. Bydureon is once a weekly drug, that is, signgle dose taken in a week would keep producing equivalent therapeutic effects of Bytta throughout the week.
Another such drugs under approval process is Taspoglutide by Roche and Albiglutide by GlaxoSmithKline. These all diabetes medications are modified to stay in body and keep controlling diabetes for 6-7 days instead of hours.
Long action of these drugs is because of half life of active ingredient. Half life of active ingredients of these drugs is 6-7 days. The drug will keep producing its intended therapeutic effects as long as it stays in human albumin.
Taspoglutide, as declared by Roche, has shown great result in phase 3 trial conducted to acquire approval by FDA. If everything goes well in trial, Taspoglutide would hit USA market in 2011.
FDA has set 22 October 2010 to collect fee for fund Bydureon approval process. Other examinations such as manufacturing process clarification, prescribing information and risk study is likely to finish by 2011.
Bydureon is brand name of extended exenatide. The earlier short acting version Bytta (brand name for exenatide) was approved in 2005 for treatment of Type 2 diabetes. Bydureon is once a weekly drug, that is, signgle dose taken in a week would keep producing equivalent therapeutic effects of Bytta throughout the week.
Another such drugs under approval process is Taspoglutide by Roche and Albiglutide by GlaxoSmithKline. These all diabetes medications are modified to stay in body and keep controlling diabetes for 6-7 days instead of hours.
Long action of these drugs is because of half life of active ingredient. Half life of active ingredients of these drugs is 6-7 days. The drug will keep producing its intended therapeutic effects as long as it stays in human albumin.
Taspoglutide, as declared by Roche, has shown great result in phase 3 trial conducted to acquire approval by FDA. If everything goes well in trial, Taspoglutide would hit USA market in 2011.
FDA has set 22 October 2010 to collect fee for fund Bydureon approval process. Other examinations such as manufacturing process clarification, prescribing information and risk study is likely to finish by 2011.
No comments:
Post a Comment