A mixed day for Shire has seen the firm get the thumbs-up from US regulators for Firazyr as a treatment for hereditary angioedema but abandon development on the skin substitute Dermagraft for venous leg ulcers.
First up, and as expected, the US Food and Drug Administration has granted marketing approval for Firazyr (icatibant injection) for acute attacks of HAE. It is a rare genetic disorder characterised by recurring and sudden attacks of swelling in the skin (including hands, feet, face and genitals) or the mucous membranes (gastrointestinal tract, larynx or voicebox).
The approval comes two months after the agency's Pulmonary-Allergy Drugs Advisory Committee backed the treatment by a vote of 12-1; the panel also voted 11-1 (with one abstention) to recommend self-administration of the drug, Firazyr is already available in the European Union.
Dermagraft fails Phase III trial
The Firazyr approval came just after Shire revealed that Dermagraft, its recently-acquired regenerative bio-engineered skin substitute already used for diabetic foot ulcers, has failed in a Phase III trial in subjects with venous leg ulcers.
The company noted that following preliminary analysis of the top-line results from the 500-plus patient trial, the decision has been made not to pursue the venous leg ulcer indication. Although when combined with compression therapy Dermagraft achieved a higher closure rate of venous leg ulcers than compression therapy alone, the data did not meet the primary endpoint mutually agreed upon with the FDA and the European Medicines Agency, ie complete healing by 16 weeks.
A venous leg ulcer indication would have expanded the utility of Dermagraft, gained through the $750 million acquisition of the USA's Advanced BioHealing, in a chronic wound setting. The failure of the trial has spooked some investors and its stock slipped 2.8% to £19.55.