Product approved to treat patients with hemophilia A and inhibitors

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Emicizumab (Hemlibra)
Photo from Business Wire
The US Food and Drug Administration (FDA) has approved use of emicizumab-kxwh (Hemlibra®), a bispecific factor IXa- and factor X-directed antibody. Emicizumab is approved as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children who have hemophilia A and factor VIII... [Read Article]
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FDA approves generic clofarabine

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Micrograph showing
acute lymphoblastic leukemia
The US Food and Drug Administration (FDA) has approved Dr. Reddy’s Laboratories Ltd.’s Clofarabine Injection, a therapeutic equivalent generic version of Clolar® (clofarabine) Injection. The generic drug is now approved to treat patients age 1 to 21 who have relapsed or refractory acute lymphoblastic leukemia and have received at... [Read Article]
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Generic azacitidine approved in Canada

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Micrograph showing
acute myeloid leukemia
Health Canada has approved Dr. Reddy’s Laboratories Ltd.’s Azacitidine for Injection 100 mg/vial, a bioequivalent generic version of VIDAZA® (azacitidine for injection). The generic drug is approved for the same indications as VIDAZA®. This includes treating adults with intermediate-2 or high-risk myelodysplastic syndromes (according to the International... [Read Article]
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CHMP backs therapy for hemophilia A

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Antihemophilic factor
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for rurioctocog alfa pegol (Adynovi). Rurioctocog alfa pegol (formerly BAX 855) is a pegylated, full-length, recombinant factor VIII product built on a licensed recombinant factor VIII product (Advate). The CHMP is recommending that rurioctocog alfa... [Read Article]
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CHMP wants to expand use of BV to include CTCL

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Micrograph showing
mycosis fungoides
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approved indication for brentuximab vedotin (BV, Adcetris). The CHMP is recommending authorization of BV to treat adults with CD30+ cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy. The... [Read Article]
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CHMP recommends letermovir as CMV prophylaxis

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HSCT preparation
Photo by Chad McNeeley
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for letermovir (Prevymis), which belongs to a class of non-nucleoside CMV inhibitors known as 3,4 dihydro-quinazolines. The CHMP is advocating that letermovir be approved as prophylaxis for cytomegalovirus (CMV) reactivation and... [Read Article]
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