Protocols

Equillium’s immuno-inflammatory drug wins FDA’s orphan drug status; Vanda sues FDA for mandating lengthy dog study

→ San Diego-based Equillium has nabbed an orphan drug designation for EQ001 on the verge of beginning a Phase Ib/II for the immuno-inflammatory drug. Also known as itolizumab, the drug was in-licensed from India’s Biocon, which sells it in the country as a psoriasis treatment. Equillium $EQ, however, is focusing its US clinical work on the prevention and treatment of acute graft-versus-host disease — a strategy that has allowed it to skip financing rounds and jump straight into an IPO.

→ Earlier this week, Pain Therapeutics $PTIE directed its ire against the “FDA’s purported shambolic regulations.” On the same day Vanda Pharmaceuticals $VNDA also fumed at the agency, saying the US health regulator had imposed a non-binding requirement that a nine-month non-rodent toxicity study be conducted before its drug, tradipitant, can be studied in humans. The company is testing the drug in a 12-week dog study, but the agency is insisting on a 9-month study. When Vanda refused to conduct this study, which usually involves young beagles as the test subjects that must be sacrificed to permit evaluation of the animal’s tissues, the FDA slapped a partial clinical hold on Vanda trials testing tradipitant for longer than 12 weeks and did not provide a justification for its decision, the company said. Consequently, Vanda has sued the agency.

“The FDA is ignoring a large body of published scientific evidence which concludes that these chronic dog studies do not offer any additional useful information. That policy is based on old, outdated science and requires the killing of too many dogs without any scientifically justified purpose. Yet, companies have been reticent to stand up to the FDA and demand that it change its policy. Vanda is unwilling to accept the status quo,” company chief Mihael Polymeropoulos said in a statement. The allegations by Vanda — which also issued an open letter to the FDA — come months after the agency said it was working on new regulations to reduce dog testing in drug development.


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