Akari Therapeutics, Plc., a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, appointed Beth-Anne Lang, senior vice president, regulatory Affairs. Lang has more than 20 years of experience in regulatory strategy, regulatory affairs, and drug development. Lang begins her new role at Akari on September 1, 2023.

Before joining Akari, Lang was senior VP regulatory affairs and pharmacovigilance for Enzyvant Therapeutics, where she led regulatory strategy, drug safety and operations to support therapeutics for rare diseases including congenital athymia and pulmonary arterial hypertension. Previously, she was VP regulatory affairs for Horizon Therapeutics, leading a global regulatory organization and directing regulatory strategy ahead of the acquisition of Viela Bio and subsequent integration. 

Lang also served as VP global head of regulatory affairs at LEO Pharma A/S, where she led all aspects of global regulatory and the local support for various global locations.

“Beth has a long track record of successful drug approvals in the U.S. and rest of world,” said Rachelle Jacques, President, and CEO of Akari. “Her extensive experience will be instrumental as we approach key development milestones and advance our two registrational Phase 3 clinical trials in pediatric and adult HSCT-TMA and bring our PAS-nomacopan program into the clinic. Speed matters for patients with significant unmet needs and Beth’s experience and capabilities are invaluable as we urgently pursue the regulatory filings that may give patients access to this potential treatment option.”

“There has been great progress to date on Akari’s priority pipeline programs, including granting of rare pediatric disease, orphan drug, and other important designations,” said Lang. “I am delighted to join the company at this exciting time as we finalize study design for the pivotal portions of nomacopan Phase 3 clinical trials in HSCT-TMA, prepare to enter the clinic with PAS-nomacopan as a potential treatment for geographic atrophy, and plan for key interactions with the FDA and other regulatory authorities.”