The FDA is trying to get tough in the wake of the controversy over Glaxo's Avandia diabetes pill, which was tied to an increased cardiovascular risk and garnered a Black Box warning. The agency today issued a new guidance calling for drugmakers to provide evidence their Type 2 diabetes meds will not increase CV risks (here it is).
"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," Mary Parks, who heads the Metabolism and Endocrinology Products division at the Center for Drug Evaluation and Research, in a statement. "FDA's guidance outlines the agency's recommendations for doing such an assessment."
Patients with diabetes have a 2 to 4 times greater risk of heart disease, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk, the FDA says in its statement. And so the new guidance, which is effective immediately, spells out new design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required.
Specifically, the guidance recommends that these studies demonstrate that "new anti-diabetic therapies do not increase cardiovascular risk in comparison with existing therapies - especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment," according to the FDA.
In an investor note, Jason Butler, a Rodman & Renshaw analyst wrote the initial take away is "much the same" as an advisory panel recommendation last July that CV assessments should be part of the approval process, but the could extend development time for new drugs and lower profitability if large post-marketing trials are needed. And this could have more impact on smaller companies.
"There is an increased possibility that drugs in late-stage development, and currently under registration review at the agency, will be delayed should the FDA view the data from ongoing completed clinical trials as insufficient to demonstrate an acceptable risk ratio."
The FDA also recommends that drugmakers and biotechs have any CV events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA says it can better ensure that product labeling includes comprehensive information on safety and effectiveness.
The FDA, meanwhile, says it continues to evaluate how the guidance will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future. The agency has also given the guidance to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatments.