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Agency Approved Drugs

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Oxlumo™

OXLUMO (lumasiran) is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

Therapy Area: Rare Disease

Agency: EMA

Veklury®

VEKLURY (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Therapy Area: Antiviral

Agency: FDA

Onureg®

ONUREG (azacitidine) is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Therapy Area: Rare Disease

Agency: FDA

Givlaari®

GIVLAARI (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria.

Therapy Area: Rare Disease

Agency: FDA

Tegsedi®

TEGSEDI (inotersen) is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Therapy Area: Rare Disease

Agency: FDA

Waylivra®

WAYLIVRA (volanesorsen) is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.

Therapy Area: Rare Disease

Agency: EMA Conditional Approval

Inqovi®

INQOVI (decitabine and cedazuridine tablet) is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following FrenchAmerican-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

Therapy Area: Oncology

Agency: FDA

Pomalyst®

POMALYST (pomalidomide), which was granted priority review designation and breakthrough therapy designation by the FDA, received an expanded indication to include treating adult patients with AIDS-related Kaposi Sarcoma after failure of highly active antiretroviral therapy and Kaposi Sarcoma in adult patients who are HIV-negative.

Therapy Area: Oncology

Agency: FDA

Triferic®

TRIFERIC (ferric pyrophosphate citrate) is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Therapy Area: Oncology

Agency: FDA

Ruxience®

RUXIENCE (rituximab-pvvr) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.

Therapy Area: Oncology

Agency: FDA

Zirabev®

ZIRABEV (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.

Therapy Area: Oncology

Agency: FDA

Firdapse®

FIRDAPSE is a potassiumchannel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

Therapy Area: Neurology

Agency: FDA

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