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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD).
Ruxolitinib is a JAK1/2 inhibitor that is already FDA-approved to treat patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
The drug is also approved to treat patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
Ruxolitinib is marketed as Jakafi by Incyte in the US and as Jakavi by Novartis outside the US.
“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, MD, Incyte’s chief medical officer.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need. 
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD).
Ruxolitinib is a JAK1/2 inhibitor that is already FDA-approved to treat patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
The drug is also approved to treat patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
Ruxolitinib is marketed as Jakafi by Incyte in the US and as Jakavi by Novartis outside the US.
“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, MD, Incyte’s chief medical officer.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.
Photo from Business Wire
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD).
Ruxolitinib is a JAK1/2 inhibitor that is already FDA-approved to treat patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
The drug is also approved to treat patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
Ruxolitinib is marketed as Jakafi by Incyte in the US and as Jakavi by Novartis outside the US.
“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, MD, Incyte’s chief medical officer.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of new therapies for serious or life-threatening conditions.
To earn the designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.