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Lovotibeglogene autotemcel, sold under the brand name Lyfgenia, is a lentiviral gene therapy used for the treatment of sickle cell disease. [1] [3] [4] [5]The most common side effects include stomatitis (mouth sores of the lips, mouth, and throat), low levels of platelets, white blood cells, and red blood cells, and febrile neutropenia (fever and low white blood cell count), consistent with ...
Betibeglogene autotemcel, sold under the brand name Zynteglo, is a gene therapy for the treatment for beta thalassemia. [ 1 ] [ 5 ] [ 2 ] It was developed by Bluebird Bio and was given breakthrough therapy designation by the US Food and Drug Administration in February 2015.
The FDA on Friday also approved a second treatment for sickle cell disease, called Lyfgenia, a gene therapy from drugmaker Bluebird Bio. Both treatments work by genetically modifying a patient’s ...
The FDA has added a warning to Lyfgenia's label on the risk of blood cancer after acute myeloid leukemia was found in two patients in bluebird's trial. FDA officials said it had not seen such ...
bluebird bio, Inc., based in Somerville, Massachusetts, is a biotechnology company that develops gene therapies for severe genetic disorders. [1]The company's only - in the European Union (EU) - approved drug is betibeglogene autotemcel (Zynteglo), which treats transfusion-dependent beta thalassemia (TDT), a rare genetic blood disorder, and has been approved for use by the European Medicines ...
In December, the FDA approved the first two cell-based gene therapies for treating sickle cell disease: Casgevy and Lyfgenia. And, like any emerging medical technology, the initial use of the ...
Lovotibeglogene autotemcel (Lyfgenia): treatment for sickle cell disease. [11] Nadofaragene firadenovec (Adstiladrin): treatment for bladder cancer [13] Obecabtagene autoleucel (Aucatzyl): treatment of acute lymphoblastic leukemia [14] [15] Onasemnogene abeparvovec (Zolgensma): AAV-based treatment for spinal muscular atrophy [16]
The US Food and Drug Administration on Friday approved two gene-based treatments for sickle cell disease, including the first therapy that uses the gene-editing technique CRISPR, opening a new era ...