WASHINGTON - Cardiovascular risks have prompted the Food and Drug Administration (FDA) of the US to impose additional clinical testing on type II diabetes drugs.
Lately the FDA has been under major scrutiny for the approvals of Avandia and Actos, which now carry strong black box warnings for increased risk of heart failure.
Until now, the FDA only required that type II antidiabetics lower blood-sugar levels.
The first victim of these new guidelines is likely to be the drug maker Takeda and its highly anticipated Alogliptin, a DPP-IV inhibitor. According to a report, ‘Diabetes Market Forecast to 2013′, analysts expect sales of $110 million for alogliptin in 2009.
To date, the drug is yet to be approved, and the FDA has extended the review deadline to June 26. Alogliptin may also have the distinction of becoming the first diabetes drug to face the new cardiovascular hurdles.
If Takeda has not collected enough information on the heart risks associated with Alogliptin, the FDA may ask the drug maker to design a new Phase III trial that does.
‘Concerns over side-effects have put a damper on sales of the major type II antidiabetics,’ said Jeremy Spivey, lead research analyst for a report on the subject.
‘These new FDA guidelines also threaten to freeze smaller companies out of the development process because it will become too costly to design their own Phase III trials.’
Some companies, such as Merck, have decided to be proactive about the new changes. Merck has announced that it will launch a post-approval study on the cardiovascular risks of its blockbuster diabetes drug Januvia, said a release of cuttingedgeinfo.
Studies of this nature are costly, but not performing them (in the case of Avandia) can be even more costly to a company’s reputation and, ultimately, to its bottom line.
For more information one can log on to www.cuttingedgeinfo.com/Diabetes/index.htm.