Vascepa - A revised Anchor Approval on Re-submission down the road?
I've been saying that the FDA needs to see the people with CVE risks/target group language eliminated from the Anchor Application.
The case below is an example of what I am hoping happens...
In our case (maybe):
We get the Letter explaining why we will not get Anchor, we negotiate a change in the Submission language, resubmit, and get a conditional approval like one or two of the AdCom Board Members asked for...
Any thoughts?
JohnKing29
Vivus: Qsymia for Obesity
Like Protalix, Vivus (VVUS) successfully negotiated a SPA agreement for key elements of the pivotal Phase 3 clinical trials of Qsymia for the treatment of obesity and weight-related co-morbidities in 2007. The Phase 3 program would include two pivotal, double blind, placebo-controlled, multi-center studies in distinct populations (EQUIP and CONQUER) comparing Qsymia to placebo during a 56-week treatment period. The program would also include a six-month confirmatory factorial study, known as EQUATE in obese subjects with BMI’s from 30 to 45. This trial would evaluate two dose levels of Qsymia, compared to both placebo and the individual constituents of the combination. The co-primary endpoints for these studies would be to evaluate the differences between treatments in mean percent weight loss from baseline to the end of the treatment period, and the differences between treatments in the percentage of subjects achieving weight loss of 5% or more. All 3 trials were initiated in 2007. The company reported positive results from EQUATE in December 2008, and highly positive results from EQUIP and CONQUER in September 2009. These studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qsymia, as compared to placebo. Patients taking Qsymia also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes. The company submitted an NDA in December 2009 which was accepted for a standard review and PDUFA goal of October 28, 2010. The NDA was reviewed by an Endocrinologic and Metabolic Drugs Advisory Committee on July 15, 2010. However the Committee voted 10:6 against approval citing concerns with the adverse events observed with treatment, including depression, anxiety, sleep disorders, other cognitive disorders, metabolic acidosis, increased heart rate and an unclear potential for teratogenicity in both animals and humans. Subsequently a CRL was issued at the PDUFA goal date.
A number of meetings and communications took place between the sponsor and Agency between December 2010 and September 2011. A new route to resubmission was agreed upon seeking initial approval for an indication restricted to obese men and women of non-child bearing potential, until further retrospective studies could be completed to fully evaluate teratogenic risk. Vivus resubmitted the NDA with a proposed contraindication in women of childbearing potential in October 2011, which was accepted as a class 2 resubmission, 6 month review cycle and a PDUFA goal was set for April 17, 2012. The sponsor was notified that the resubmitted NDA would again be reviewed by an Advisory Committee. In January 2012, FDA requested that Vivus remove the Qsymia contraindication for women of childbearing potential contained in the proposed label. Qsymia would remain contraindicated for women who are pregnant. On February 22, 2012, the Endocrinologic and Metabolic Drugs Advisory Committee voted 20 to 2 in favor of approval for the drug contingent on an adequate Risk Evaluation and Mitigation Strategy (REMS) and with post-marketing safety studies. Finalization of the REMS program necessitated a 3-month extension for the PDUFA goal taking it to July 17, 2012. Qsymia was finally approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia) on July 17, 2012.
AI
