Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals

Table 5 Indications excluded from selected analyses^a on the basis of disproportionately low disease prevalence among those aged ≥65 years

Drug	Indication
Rilpivirine hydrochloride	Human immunodeficiency Virus
Spinosad	Lice
Telaprevir	Hepatitis C
Brentuximab vedotin	Hodgkin lymphoma
Brentuximab vedotin	Large-cell lymphoma
Clobazam	Lennox-Gastaut syndrome
Boceprevir	Hepatitis C
Belimumab	SLE
Lucinactant	Respiratory distress syndrome
Taliglucerase alfa	Gaucher disease
Ivacaftor	Cystic fibrosis
Crofelemer	Patients with diarrhea and Human immunodeficiency Virus infection on antiretroviral therapy
Teriflunomide	Relapsing multiple sclerosis
Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	Human immunodeficiency Virus
Lomitapide mesylate	Homozygous familial hypercholesterolemia
Mipomersen sodium	Homozygous familial hypercholesterolemia
Dimethyl fumarate	Relapsing remitting multiple sclerosis
Macitentan	Pulmonary arterial hypertension (WHO group 1)
Dolutegravir sodium	Human immunodeficiency Virus
Riociguat	Persistent/recurrent CTEPH (WHO group 4) after surgery or inoperable CTEPH to improve exercise capacity and WHO functional class
Riociguat	Pulmonary arterial hypertension (WHO group 1) to improve exercise capacity, WHO class, delay functional worsening
Simeprevir sodium	Hepatitis C

CTEPH chronic thromboembolic pulmonary hypertension, SLE systemic lupus erythematosus, WHO World Health Organization
^aAs described in detail within the main text

ISSN: 1745-6215