Chronic Fatigue Syndrome Drug Development Efforts Get A Boost From FDA
This article was originally published in The Pink Sheet Daily
Agency is undertaking a series of activities with patients, advocacy groups and other stakeholders aimed at spurring development of new treatments. Hemispherx is hoping its investigational drug Ampligen, currently under FDA review, will become an early beneficiary of new statutory provisions on expedited approval.
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Clinical trial efficacy endpoints for investigational CFS/ME drugs should include patient-reported symptoms, but FDA is open to the use of instruments evaluated in other populations for this purpose, agency says in a new draft guidance.
FDA is bringing an ongoing program to spur drug development for CFS and myalgic encephalomyelitis under the umbrella of the user fee program’s Patient-Focused Drug Development initiative, which calls for 20 patient-centric meetings over five years.
In a “complete response” letter, FDA requested at least one new clinical trial, along with nonclinical studies and numerous data analyses, before approval of the chronic fatigue syndrome drug. Hemispherx continues to assert the existing data support approval and plans an appeal to FDA’s Office of New Drugs.