Pharmacy |

Health Canada approves emicizumab

Published on August 8, 2018August 8, 2018 by HT Staff

Emicizumab (Hemlibra)
Photo from Business Wire

Health Canada has approved emicizumab (Hemlibra®) for use as routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A patients with factor VIII inhibitors. Emicizumab is a bispecific factor IXa- and factor X-directed antibody. It bridges activated factor IX and factor X to restore the natural function of... [Read Article]

CHMP recommends generic deferiprone

Published on August 1, 2018July 31, 2018 by HT Staff

Micrograph showing thalassemia

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Deferiprone Lipomed to treat iron overload in patients with thalassemia major. Deferiprone Lipomed is a generic version of the iron chelating agent Ferriprox, which has been authorized in the European Union since August 1999. According to... [Read Article]

CHMP backs generic lenalidomide

Published on August 1, 2018July 31, 2018 by HT Staff

Lenalidomide (Revlimid)
Photo courtesy of Celgene

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Lenalidomide Accord as a treatment for multiple myeloma (MM). Lenalidomide Accord is a generic version of Revlimid, which has been authorized in the European Union since June 2007. The CHMP said studies have... [Read Article]

CHMP recommends expanded approval for daratumumab

Published on July 31, 2018July 31, 2018 by HT Staff

Daratumumab (Darzalex)
Photo courtesy of Janssen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorization for daratumumab (Darzalex). The CHMP is recommending approval for daratumumab in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of adults with newly diagnosed multiple myeloma (MM) who... [Read Article]

CHMP announces 2 opinions on blinatumomab

Published on July 31, 2018July 31, 2018 by HT Staff

Vials of blinatumomab
powder and solution
Photo courtesy of Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has released 2 new opinions regarding blinatumomab (Blincyto). The CHMP recommended expanding the approved use of blinatumomab to include pediatric patients, but the committee also recommended against approving blinatumomab to treat patients with... [Read Article]

CHMP supports expanded approval for epoetin alfa products

Published on July 31, 2018July 31, 2018 by HT Staff

Red blood cells

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the terms of marketing authorization for 3 versions of epoetin alfa—Abseamed, Binocrit, and Epoetin alfa Hexal. The CHMP is recommending that all 3 products be approved to treat symptomatic anemia (hemoglobin concentration of ≤ 10... [Read Article]

CHMP backs 2 biosimilar pegfilgrastim products

Published on July 31, 2018July 31, 2018 by HT Staff

Neulasta Onpro Kit
Photo from Amgen

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 pegfilgrastim biosimilar candidates—Udenyca and Pelgraz. Both products have been deemed highly similar to the reference product, Neulasta, a growth-colony-stimulating factor intended to reduce the duration of neutropenia and the incidence of febrile... [Read Article]

CHMP issues final negative opinion of betrixaban

Published on July 31, 2018July 31, 2018 by HT Staff

Thrombus
Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reiterated its negative opinion of betrixaban. Once again, the CHMP has concluded that it cannot recommend approval of betrixaban for the prevention of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness with risk... [Read Article]

CHMP recommends expanded approval for rivaroxaban

Published on July 31, 2018July 31, 2018 by HT Staff

Prescription drugs
Photo courtesy of the CDC

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a new indication for rivaroxaban (Xarelto) 2.5 mg tablets. The recommendation is for rivaroxaban co-administered with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adults with coronary artery disease or symptomatic peripheral... [Read Article]

FDA approves drug for IDH1-mutated AML

Published on July 23, 2018July 20, 2018 by HT Staff

Ivosidenib (Tibsovo®)
Photo courtesy of
Agios Pharmaceuticals

The US Food and Drug Administration (FDA) has granted full approval for the isocitrate dehydrogenase-1 (IDH1) inhibitor ivosidenib (Tibsovo®). The drug is approved to treat adults with relapsed or refractory acute myeloid leukemia (AML) who have an IDH1 mutation, as detected by an FDA-approved test. Ivosidenib was approved... [Read Article]

Health Canada expands approval of obinutuzumab

Published on July 10, 2018July 9, 2018 by HT Staff

Obinutuzumab (Gazyva)

Health Canada has expanded the approved use of obinutuzumab (Gazyva®). The anti-CD20 monoclonal antibody is now approved for use in combination with chemotherapy to treat patients with previously untreated follicular lymphoma (FL) that is advanced (stage II bulky, stage III, or stage IV). In patients who respond to this treatment, obinutuzumab monotherapy can... [Read Article]

EC approves new use, formulation of dasatinib

Published on July 6, 2018July 5, 2018 by HT Staff

Doctor consults with
cancer patient and her father
Photo by Rhoda Baer

The European Commission (EC) has expanded the marketing authorization for dasatinib (Sprycel). The drug is now approved to treat patients ages 1 to 18 with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). The EC has also approved a new... [Read Article]

CHMP recommends CAR T for ALL, DLBCL

Published on July 2, 2018July 1, 2018 by HT Staff

Tisagenlecleucel (Kymriah)
Photo courtesy of Novartis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of tisagenlecleucel (Kymriah®, formerly CTL019) for 2 indications. According to the CHMP, the chimeric antigen receptor (CAR) T-cell therapy should be approved to treat adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL)... [Read Article]