argenx receives feedback from FDA in end-of-phase 2 meeting for efgartigimod in myasthenia gravis

argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced the receipt of guidance from the U.S. Food & Drug Administration (FDA) following an End-of-Phase 2 meeting.

As quoted in the press release:

argenx expects to initiate a global pivotal Phase 3 clinical trial of efgartigimod in gMG before the end of 2018. The placebo-controlled 26-week trial is expected to evaluate the efficacy of a 10 mg/kg dose of efgartigimod in approximately 150 gMG patients, including both AChR autoantibody positive and AChR autoantibody negative patients. In addition, patients can roll over into an open-label extension study for a period of one year.

“The outcome of the End-of-Phase 2 meeting is an important step in our strategic plan to advance efgartigimod in gMG patients. We plan to proceed with one study and one dose for our path to approval, and to include AChR autoantibody negative patients in our recruitment plan as this subset represents a particular high unmet need among the MG population,” commented Nicolas Leupin, CMO of argenx. “We believe our Phase 3 clinical trial, in combination with the positive Phase 2 data, has the potential to support a BLA submission. We will continue to work very closely with the regulatory authorities as we advance efgartigimod towards approval to help patients suffering from this severe autoimmune disease.”

Click here to read the full press release.