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= Achieved
Pharmaceutical Pipeline – Key Events in 2023*
POTENTIAL APPROVALS US/EU
niraparib
L1 Prostate cancer metastatic castration-resistant in combination with abiraterone acetate and Prednisone
EU
talquetamab (GPRC5D/CD3)
Relapsed Refractory Multiple Myeloma
US
EU
ERLEADA (apalutamide)
Tablet Reduction
US
EU
aprocitentan
Difficult to treat hypertension
US
EDURANT (rilpivirine)
HIV pediatric 2-12 year old
US
PLANNED SUBMISSIONS US/EU
niraparib
L1 Prostate cancer metastatic castration-resistant in combination with abiraterone acetate and Prednisone
US
talquetamab (GPRC5D/CD3)
Relapsed Refractory Multiple Myeloma
EU
BALVERSA (erdafitinib)
Urothelial cancer
US
EU
aprocitentan
Difficult to treat hypertension
EU
EDURANT (rilpivirine)
HIV pediatric 2-12 year old
US
EU
OPSUMIT (macitentan)
Pediatric pulmonary arterial hypertension
EU
macitentan w/tadalafil FDC
Pulmonary arterial hypertension
US
EU
VAC18193
RSV Adult Vaccine
US
EU
POTENTIAL CLINICAL DATA
Phase III
IMBRUVICA (ibrutinib)
Relapsed Refractory patients with Mantle Cell Lymphoma in combination with venetoclax (SYMPATICO)
DARZALEX (daratumumab)
Frontline multiple myeloma transplant ineligible (CEPHEUS)
CARVYKTI (ciltacabtagene autoleucel)
Relapsed Refractory multiple myeloma w/1-3 PL (CARTITUDE-4)
BALVERSA (erdafitinib)
Urothelial cancer (THOR)
RYBREVANT (amivantamab)
Frontline Non Small Cell Lung Cancer in combination with chemotherapy (PAPILLON)
OPSUMIT (macitentan)
Pediatric pulmonary arterial hypertension (TOMORROW)
UPTRAVI (selexipag)
Pediatric pulmonary arterial hypertension (SALTO)
macitentan w/tadalafil FDC
Pulmonary arterial hypertension (A DUE)
SPRAVATO (esketamine)
Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)
TREMFYA (guselkumab)
Crohn's Disease
TREMFYA (guselkumab)
Ulcerative Colitis Monotherapy
Phase II
BALVERSA (erdafitinib)
Tumor Agnostic (RAGNAR)
TAR-200 (RIS/gemcitabine plus cetrelimab)
Non muscle invasive bladder cancer (SR-1 Early Data)
RYBREVANT (amivantamab)
Solid Tumors (GIC2001)
nipocalimab
Rheumatoid Arthritis
nipocalimab
Hemolytic disease of the fetus and newborn
*This information is accurate as of January 24, 2023 to the best of the Company's knowledge. Johnson & Johnson assumes no obligation to update this information.