FDA
9th August 2013

FDA Panel Recommends Riociguat (Adempas) for Pulmonary Hypertension

On Tuesday, the FDA’s Cardiovascular and Renal Drugs Advisory Committee unanimously recommended Riociguat (Adempas, Bayer Healthcare) as treatment in two forms of pulmonary hypertension; pulmonary arterial hypertension (PAH) of WHO Group 1 and chronic thromboembolic pulmonary hypertension (CTEPH) of WHO Group 4. 

FDA Panel Recommends Riociguat (Adempas) for Pulmonary Hypertension

The RESULTS are in!

On Tuesday, the FDA’s Cardiovascular and Renal Drugs Advisory Committee unanimously recommended Riociguat (Adempas, Bayer Healthcare) as treatment in two forms of pulmonary hypertension; pulmonary arterial hypertension (PAH) of WHO Group 1 and chronic thromboembolic pulmonary hypertension (CTEPH) of WHO Group 4. 

PAH and CTEPH are both life-threatening forms of pulmonary hypertension that cause significantly increased pressure in the pulmonary arteries. The data presented on Tuesday included results from the two randomized, double-blind, placebo-controlled, global Phase III studies CHEST-1 and PATENT-1 which were published in the New England Journal of Medicine (NEJM) in their July 25 (2013) issue. These studies assessed both the efficacy and safety of oral riociguat in the treatment of CTEPH and PAH respectively.  The primary endpoint in both trials was to improve exercise capacity. Secondary endpoints included pulmonary vascular resistance changes, N-terminal prohormone brain-type natriuretic peptide, WHO functional class, time to clinical worsening, Borg scores, EuroQoL 5-dimensional Classification Component scores, and Living with Pulmonary Hypertension scores. In both studies, in their respective pulmonary-hypertension populations, the drug significantly improved both pulmonary-artery (PA) hemodynamics and exercise capacity after 16 to 12 weeks respectively. Riociguat also demonstrated consistent improvements across multiple, relevant secondary endpoints, and was generally well-tolerated, with a good safety profile.

Voting member, Vasilios Papademetriou, MD, a staff cardiologist at Veterans Affairs Medical Center in Washington, DC, expressed his support of the evidence. “I thought the data were convincing and showed efficacy and acceptable safety.”

“The benefit/risk [profile] was really positive,” Dr. Philip Sager (Stanford University School of Medicine, CA) added. However, the panelists said, the concomitant use of riociguat with nitrates should be contraindicated.

Riociguat is an oral soluble guanylate cyclase stimulator that can potentiate nitric-oxide pathways. Riociguat was discovered by Bayer and is the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase (sGC). The FDA granted a Priority Review designation to the New Drug Application (NDA) for riociguat filed by Bayer in February 2013. 

The Advisory Committee’s recommendations will be considered by the FDA in its review of the riociguat NDA however, the FDA is not required to follow the advice of its panel.

 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

Interested in learning about ISS’ expert approach to Advisory Committee Meetings? Click below in order to find out for yourself!

Generic Blog CTA for Ad Comm Approach

 

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

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

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

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

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

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

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

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

Let’s work together

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 today

Contact us