On Wednesday, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) discussed the potential clinical utility of fixed-combination prescription drugs (i.e. polypill).
On Wednesday, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) discussed the potential clinical utility of fixed-combination prescription drugs (i.e. polypill) composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee was asked to discuss the specific patient population that could potentially benefit from such a product, risk mitigation and additional data or studies that may be prudent to develop for the marketing of such a product.
There were no voting questions during this meeting; however, the polypill received mostly positive feedback from CRDAC throughout the meeting’s discussions. For this meeting, the FDA limited their discussion to the use of the polypill for secondary prevention in people who have already had a MI or a stroke. The more difficult discussion regarding polypill use for primary prevention use was put off for another time. The majority of panelists agreed that the argument of polypill use for secondary prevention was more straightforward than the argument for primary prevention. CRDAC panelist Philip Sager noted that the primary issue existing for secondary prevention is that the drugs that would be contained in a polypill are now being under-utilized, not over-utilized.
The prevailing view of the panelists was that the polypill was not better than standard care or intended to replace the standard of care, but that it could be used where patient compliance/adherence is an issue and when physicians are able to treat a patient but are unable to monitor their care or follow-up appropriately due to various reasons such as geography, finances, and patient preference.
Furthermore, panelists did not see a strong need for phase 3 or outcome trials with the polypill; however, they expressed interest in studies that could observe the effect of the polypill on patient adherence and monitor or assess possible safety issues related to the polypill.
Panel member James De Lemos, MD, Professor of Medicine at the University of Texas Southwestern Medical Center, stated the following about the meeting outcome:
“The tenor of the discussion was generally quite positive with caveats that some members wanted to see more safety and real world effectiveness data. 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.”
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us