Galapagos is a latecomer to CAR T-therapy, but the drugmaker hopes its technology for producing cell therapies at a clinical site will help it stand out. Galapagos has encouraging preliminary data from two early-stage programs and it just begun Phase 1/2 testing of its third cancer cell therapy.
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The European Commission and Japan's Ministry of Health, Labor and Welfare approved filgotinib, marketed under the name Jyseleca, for rheumatoid arthritis. The drug is partnered in Japan with Eisai. The FDA rejected the drug last month.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
An analyst wrote that while filgotinib's profile appears clean overall, even minor safety imbalances could derail its approval, while a slight imbalance in the number of deaths between the Phase III study arms could also attract scrutiny.
The collaboration includes six drugs in development and more than 20 in preclinical development. It also amends an existing four-year-old partnership the two companies had regarding the autoimmune disease drug filgotinib.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The timing of the filing appears to allay concerns that the FDA would require completion of a study evaluating the testicular safety of the drug, filgotinib, and thus push its launch date from 2020 to 2021-22, an analyst wrote.
Whether the FDA requires completion of a study to look at testicular toxicity before approval could dictate whether the drug launches next year or as late as 2022, an analyst wrote.