FDA approves listing of interferon gamma (IFN) antibody Gamifant (emapalumab-lzsg)
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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today, Sobi and Novimmune SA(http://jointly announced that the U.SFDA(http://approved the joint development of the interferon (IFN)antibody Gamifant (emapalumab-lzg) for the treatment of children or adult primary phage lymphocytic lymphocytic associtoma (HLH) patientsAbout Gamifant
Gamifant is a monoclonal antibody for IFNIt can be combined with IFN and its effectsGamifant has been granted FDA-awarded ground-breaking therapeutic stakes and orphan drug eligibility, andnew drug(http://applications have also been eligible for priority reviewGamifant was approved to be co-administered with the steroid therapy dexamethasone, administered twice a week through intravenous drips until the patient received HSCTrelated research
this approval is based on Gamifant's performance in a global, multicenter, open label, single arm critical 2/3 clinicaltrial (http:// in this trial, 27 patients with primary HLH received a combination of Gamifant and Dexamethasone These patients did not respond to conventional therapies, were poorly responsive, or intolerant results showed that Gamifant reached the main end of the trial, with a total remission rate of 63% after six months of treatment Moreover, 70% of patients continued to receive HSCT
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