The controversial pill took received a mostly positive recommendation from the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee, Forbes reports.

 

The idea for the polypill has been around for more than a decade and attracted considerable both support and skepticism.
 

The polypill is not better than standard care or intended to replace standard care, but that it could be used where adherence is a problem and when physicians are able to treat a patient but are unable to monitor their care, according to an FDA policy statement given to the committee.
 

“We believe there are patients in the USA for whom cardiovascular prevention therapy is appropriate but who cannot get the follow-up necessary … for reasons that include geography, finances, and patient preference,” the FDA wrote in its briefing to the committee.

“We are asking then whether people who are not, for whatever reason, going to receive regular follow-up are better off on some reasonable doses of drugs for secondary prevention of cardiovascular disease, rather than none, even if they are not getting what is believed to be optimal care.”
 

The FDA’s Robert Temple said that the FDA hopes that fixed-dose combination drugs, including the polypill, can improve adherence, but that the FDA has not insisted in the past improved adherence be demonstrated.
 

“The tenor of the discussion was generally quite positive with caveats that some members wanted to see more safety and real world effectiveness data,” said committee member James De Lemos.
 

“Others, including myself felt like the FDA’s stated path to approval limited to pharmacokinetic and dynamic studies would be sufficient for regulatory approval, given how much we already know about the individual components that are already used in combination routinely.”