By Anna Rose Welch, associate editor
Hemophilia A Treatment Wins FDA Approval
Last week, Baxter gained FDA approval for its acquired hemophilia A treatment, Obizur, an Antihemophilic Factor (Recombinant), Porcine Sequence treatment. Obizur underwent evaluation to determine its efficacy in treating serious bleeding episodes in adults in a Phase 2/3 clinical trial. Within 24 hours of administration, patients were showing that the drug effectively or partially stopped bleeding; 86 percent saw success taking the drug after an initial bleeding episode. As acquired hemophilia A is a rare disease, the drug was named an orphan drug and received priority review.
FDA Requests More Data From Lundbeck For Epilepsy Drug
The FDA requested more info from Lundbeck last week for its NDA for Carbella (carbamazepine) injection for epilepsy. The company hopes to address the issues listed in the Complete Response Letter and have the drug available in 2015 following FDA approval. The letter requested more information on the companys chemistry, manufacturing, and controls data. Carbella is an intravenous formulation of carbamazepinean oral drug which was originally approved by the FDA in 1968. In 2013, Carbella won orphan drug designation from the FDA.
De Vivo Disease Drug Gains Orphan Drug Designation
Ultragenyx Pharma was awarded an orphan drug designation for its triheptanoin (UX007), a treatment for glucose transporter type-1 deficiency syndrome, or Glut1 DSalso known as De Vivo disease. The drug is currently under investigation in a Phase 2 trial.
Daiichi Sankyo Atrial Fibrillation Drug Given FDA Committee Nod
The FDAs Cardiovascular and Renal Drugs Advisory Committee has given a thumbs up to Daiichi Sankyos 60 mg dose blood thinner for non-valvular atrial fibrillation, though with the specification that it would be best to limit use in patients with abnormal kidney function, Reuters reported last week. Edoxaban is an anticoagulant that is taken once daily and plays an integral part in keeping blood from clotting at the hands of Factor Xa. The panel stated last week, Although the ... overall findings support effectiveness, efficacy outcomes by baseline renal function have potential implications for approval or labeling." If formally approved, the drug would become a rival to Bayers and Johnson & Johnsons Xarelto and Pizers and Bristol-Myers Squibbs Eliquis. Known as Savaysa in the U.S., the drug is also currently undergoing review as a venous thromboembolism treatment (VTE).
GVHD Drug Named Orphan Drug
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FDA News Roundup: Baxter, Lundbeck, Daiichi Sankyo, And More