Protonix received a labeling claim of complete relief of daytime and nighttime

A recent review of PRO labels between 2006 and 2010 found that almost half of all drug approval pack age submissions included PROs and that a vast majority of PRO labeling claims were granted for evidence based on the primary endpoint. The purpose of this research is to fully explore the impact of Maraviroc UK-427857 endpoint type on resultant labeling claims over a 12 ½ year period supported by PRO measures and determine if nonprimary endpoints are being fully optimized. This review will further contribute to conti nued analyses of the role of PROs in clinical trials and provide a broader perspective, including an examination of the nonprimary endpoints pre and postrelease of the FDA PRO guidance. Methods The methods for the data collection component for this research are fully described in a previous publication and are similar to those published by Willke and col leagues.

Briefly, all new molecular entities and biological license applications for new pre scription drugs approved in the United States from January 2000 through June MK-1775 ic50 2012 were reviewed. Products were excluded if they contained substances previously marketed with a different brand name or set of indica tions, in a different dosage form or strength, or as a com bination product of previously marketed entities. Once products were identified, drug approval packages and approved product labels were extracted by a single researcher and reviewed by all authors. As avail able, information was retrieved from the medical review, summary review, cross discipline team leader review, and other review sections from the DAP, as well as the indication and clinical studies section of the approved product label.

The DAPs were located on the FDA Web site, DrugsFDA. In most cases, the label was found on the FDA Web site under approval history for the drug at time of approval. In mTOR inhibition the event the approved label was unavailable for the specified timeframe, the current label was used. Relevant information was scruti nized for each product to determine the indication, use of PRO, and PRO claim language. Statistical analysis consisted of simple frequencies and cross tabulations of measured characteristics. Calculations were performed using Microsoft Excel 2007. Results A total of 308 NMEsBLAs were identified between the years 2000 and 2012. Of these, 70 NMEsBLAs were granted a total of 83 PRO claims.

A PRO was in cluded as a primary endpoint for 57 of the 70 products. The majority of product claims granted were for disease or condition specific signs and symptoms. Fewer claims included higher order measures such as function ing, HRQOL, or patient global ratings. Table 1 depicts the products that were granted PRO labeling claims by type of claim. Additionally, 19 products received a total of 29 PRO labeling claims using a PRO that was a nonprimary end point. These claim types included signs and symptoms, functioning, HRQOL, and other nocturnal asthma symptom scores, fewer nighttime awak enings and fewer nights in which patients used rescue. Import antly, of these, the vast majority were claims based on signs or symptoms, as compared with higher order claims, and were supportive of the primary endpoint. However, nonprimary endpoints were more likely to represent claims based on concepts other than signs and symptoms as compared with pri mary PRO endpoints.