Table 2.
Sample classifications of indications for studies outlined in clinical postmarketing requirements and commitments.
| Therapeutic | Original FDA approved indication | PMR/PMC: authority;a description23 | PMR/PMC study population | PMR/PMC indication classificationb |
|---|---|---|---|---|
| Lurasidone | Schizophrenia | PMC: 506B; “To evaluate the longer-term, i.e. maintenance, efficacy of lurasidone in the treatment of adults with schizophrenia…” | Adult patients with schizophrenia |
Original indication, general population |
| Simeprevir | Chronic hepatitis C infection, as a component of a combination antiviral treatment regimen | PMC: 506B; “Submit the final report and datasets for trial… [in] Subjects who are Co-Infected with Human Immunodeficiency Virus Type 1 (HIV-1)” | Chronic hepatitis C infection, with HIV-1 coinfection | Original indication, clinical subgroup |
| Linagliptin | Type 2 diabetes mellitus | PMR: PREA; “…evaluate efficacy, safety, and pharmacokinetics of linagliptin for the treatment of type 2 diabetes mellitus in pediatric patients ages 10 to 16 years…” | Pediatric patients with type 2 diabetes mellitus | Original indication, demographic subgroup |
| Cabazitaxel | Hormone-refractory metastatic prostate cancer, in combination with prednisone, for patients previously treated with a docetaxel-containing treatment regimen | PMR: FDAAA; “Conduct a Phase 3 randomized controlled trial in patients with hormone-refractory metastatic prostate cancer…with prednisone as first-line therapy.” | First-line therapy with prednisone for (i.e., previously untreated) patients with hormone-refractory metastatic prostate cancer | Modified indication |
| IncobotulinumtoxinA | Cervical dystonia and blepharospasm | PMC: 506B; “Randomized, double-blind, adequate and well controlled, multiple fixed-dose, parallel group clinical trial… [in] adults with lower extremity spasticity.” | Adult patients with lower extremity spasticity | New indication |
PMR: postmarketing requirement; PMC: postmarketing commitment; FDAAA: Food and Drug Administration Amendments Act; PREA: Pediatric Research Equity Act.
a
“506B” refers to postmarketing commitments subject to reporting requirements under section 506B of the Federal Food, Drug, and Cosmetic Act.
b
Additional example postmarketing requirement and commitment classifications are included in eAppendix 1.