The FDA on June 7, 2018 approved MIRCERA® for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. MIRCERA® is a product of Vifor Pharma Inc.
Category: FDA Approvals
FULPHILA® (Pegfilgrastim-jmdb)
The FDA on June 4, 2018 approved FULPHILA® as a biosimilar to NEULASTA® (Pegfilgrastim, Amgen, Inc.), to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer, who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. FULPHILA® is a product of Mylan GmbH.
DOPTELET® (Avatrombopag)
The FDA on May 21, 2018 approved DOPTELET® for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. DOPTELET® is a product of AkaRx Inc.
RETACRIT® (Epoetin alfa-epbx)
The FDA on May 15, 2018 approved RETACRIT® as a biosimilar to EPOGEN®/PROCRIT® (Epoetin alfa, Amgen Inc.), for the treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis, use of Zidovudine in patients with HIV infection and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. RETACRIT® is a product of Hospira Inc., a subsidiary of Pfizer Inc.
FDA Approves AndexXa®, The First Antidote for Factor Xa Inhibitors
The FDA on May 3, 2018 approved AndexXa® (Andexanet Alfa), a recombinant coagulation Factor Xa, inactivated-zhzo), for patients treated with XARELTO® (Rivaroxaban) and ELIQUIS® (Apixaban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval of AndexXa® was based on data from two Phase III ANNEXA studies (ANNEXA-A and ANNEXA-R) as well as interim data from the ongoing ANNEXA-4 study. AndexXa® significantly reduced anti-Factor Xa activity of Factor Xa Inhibitors by over 90% compared with placebo, with reversal persisting for 1 to 2 hours after completion of the infusion. The availability of this antidote assures both patients and Health Care Providers to consider Factor Xa inhibitors with greater confidence.
TAFINLAR® and MEKINIST®
The FDA on May 4, 2018 approved TAFINLAR® (Dabrafenib) and MEKINIST® (Trametinib) for Anaplastic Thyroid Cancer with BRAF V600E mutation. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Corp.
AndexXa® (Andexanet Alfa)
The FDA on May 3, 2018 approved AndexXa®, a recombinant coagulation Factor Xa, inactivated-zhzo), for patients treated with XARELTO® (Rivaroxaban) and ELIQUIS® (Apixaban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. AndexXa® is a product of Portola Pharmaceuticals.
KYMRIAH® (Tisagenlecleucel)
The FDA on May 1, 2018 approved KYMRIAH®, a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma, after two or more lines of systemic therapy including Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from Follicular Lymphoma. KYMRIAH® is a product of Novartis Pharmaceuticals Corp.
TAFINLAR® and MEKINIST®
The FDA on April 30, 2018 granted regular approval to TAFINLAR® (Dabrafenib) and MEKINIST® (Trametinib), in combination, for the adjuvant treatment of patients with Melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Corp.
TAGRISSO® (Osimertinib)
The FDA on April 19, 2018 approved TAGRISSO® for the first-line treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC), whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. TAGRISSO® is a product of AstraZeneca Pharmaceuticals LP.