FDA Confirms Paragraph IV Patent Litigation for Fedratinib Hydrochloride
NICE have issued a final appraisal determination (FAD) recommending the nuse of Inrebic (fedratinib) on the NHS for the treatment of nmyelofibrosis, a rare blood cancer affecting the bone marrow and ndisrupting the body’s production of blood cells. Eligible adult patientsnwith primary or secondary myelofibrosis will now be able to access nfedratinib on the NHS.
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Inrebic® (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, Inrebic will be the first, once-daily oral therapy to significantly reduce spleen volume and symptom burden for patients with myelofibrosis where treatment with ruxolitinib has failed or who are JAK inhibitor naïve.
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Inrebic® (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, Inrebic will be the first, once-daily oral therapy to significantly reduce spleen volume and symptom burden for patients with myelofibrosis where treatment with ruxolitinib has failed or who are JAK inhibitor naïve.
MONTREAL, Sept. 21, 2020 /CNW/ - Bristol Myers Squibb Canada (BMS) announced today that Health Canada has approved INREBIC® (fedratinib), a new once-daily oral medication used to treat adults with an enlarged spleen and associated symptoms caused by intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.1
In its final days as an independent company, Celgene scored a win last month with the FDA's approval of rare blood disease med Reblozyl––a potential blockbuster in some analysts' eyes. Now, the FDA wants a closer look at Reblozyl as a treatment for a group of rare blood cancers.
September does not look to be a very busy month for the U.S. Food and Drug Administration (FDA), at least not for scheduled drug approvals. However, in the first two weeks of September there were three scheduled PDUFA dates. One of those dates, for Celgene’s myelofibrosis drug, was approved early. Here’s a look.
Celgene’s Inrebic becomes the first treatment for myelofibrosis to be approved by the US FDA since 2011 after having received a priority review and orphan drug designation.
The U.S. Food and Drug Administration has approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis, that has not responded to conservative treatment options, such as external bracing. The device, called The Tether – Vertebral Body Tethering System, is intended to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option.
Celgene Corporation announced that the US Food and Drug Administration (FDA) has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.