Today, a brief rundown of news involving the Food and Drug Administration and Biogen, as well as updates from Argenx and Blackstone Life Sciences and that you may have missed.
Pierre Fabre Laboratories has aligned with the Food and Drug Administration on a path forward for a cell therapy called Ebvallo that the regulator has twice rejected. According to a Thursday release from Pierre Fabre, the agency agreed that data from a single arm study with an “appropriate historical control” would be sufficient for a resubmission of Ebvallo, which is being developed for a kind of post-organ transplant malignancy. Those results will come via new findings from an ongoing Phase 3 trial, with Pierre Fabre providing updated results with additional pateints and longer follow-up. Pierre Fabre's partner Atara Biotherapeutics has claimed that the FDA backtracked from an earlier position when it spurned Ebvallo in January — one of several alleged regulatory U-turns that have sparked criticism of the agency.
The FDA delayed by three months a decision to approve a more convenient starting dose of Biogen and Eisai’s Alzheimer’s drug Leqembi, the companies said Friday. The subcutaneous version of the drug, known as Leqembi Iqlik, is already cleared for use as a maintenance therapy following 18 months of intravenous infusions. The partners hoped to make Leqembi Iqlik available as an initial, weekly therapy, too. The FDA, though, has requested additional information that it deems a “major amendment” to the companies’ filing and needs more time to review that data. The agency hasn’t raised “any concerns to date” about the drug’s approvability, but a new decision date has been set for Aug. 24, the companies said.
Argenx has named current Chief Operating Officer Karen Massey as its next CEO. In a Wednesday statement , the company said that Massey was confirmed as Argenx’s leader at a shareholder meeting and will take over for co-founder and longtime CEO Tim Van Hauwermeiren, who's held the position since 2008 and helped grow Argenx into one of the biotech sector's most valuable companies. Massey has been serving as Argenx's COO since joining the company in 2023 and “has played a central role in shaping [the company’s] execution and long-term growth strategy,” Van Hauwermeiren said in a statement. Van Hauwermeiren will chair Argenx's board going forward.
Blackstone Life Sciences is investing $250 million in a privately-held company developing a treatment for people with a pancreatic condition often associated with cystic fibrosis. The investment in Anagram Therapeutics will help fund the development, approval and potential launch of ANG003, an experimental drug for “exocrine pancreatic insufficiency,” when the pancreas doesn't make enough digestive enzymes to break down food. ANG003 is an oral replacement therapy for those enzymes, and would provide an alternative to regimens that can involve up to 40 pills per day, Blackstone said Thursday. Anagram is preparing to start an international Phase 2 study.
