Edwards Lifesciences ($EW) scored a major win on Wednesday, successfully making its case before an FDA panel of experts that its Sapien transcatheter heart valve should be used in a broader class of patients. The agency's Circulatory Systems Advisory Committee voted 11-0 (one panelist abstained) that the benefits outweighed any risks in using the valve for patients with severe aortic stenosis who are high-risk but could otherwise undergo surgery.
Investors reacted favorably, driving Edwards' stock up more than 8% to $98.55 by midday on June 14.
Bloomberg, MedPage Today, The Associated Press, CardiovascularBusiness and many others covered the day-long panel meeting and final vote. While the FDA doesn't have to follow the panel's recommendation, it usually does. Panel members also voted 12-0 that Sapien is effective and 10-2 that the valve is safe.
When the FDA comes out with its final decision is anyone's guess, but Bloomberg predicts final action could come in October, based on the timeline for Sapien's initial approval in 2011 (panel meeting in July; regulatory approval in November). Sapien initially gained FDA approval for patients with limited classes of stenosis who can't have surgery.
To make its case during the 8-hour-plus hearing, Edwards Life Sciences relied on the "Cohort B" part of its pivotal PARTNER trial, which compared transcatheter aortic valve implantation (TAVI) with surgery. ("Cohort A" was used for the initial approval in November.)The trial involved 699 older patients of high risk with severe aortic stenosis who were randomly assigned to the TAVI procedure or surgery. Among the findings: the death rate was similar for both, but patients who had transcatheter aortic valve implantation faced double the rate of stroke over the initial 30-day period after the surgery. That finding concerned both FDA scientists and panel members, though Edwards countered that stroke rates evened out after another year, Bloomberg notes. Regulators in advance of the hearing were also bothered by how the company chose patients and categorized them for the trial, arguing that it constituted bias to some degree, and potentially skewed the results.
Edwards wants to do a post-approval study to follow patients from the trial and also create a registry to enroll new patients. FDA staff members agree, and urged at least 5 years of follow-up for subjects from the trial.