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Shire's rare-disease treatment granted Health Canada priority review

Shire PLC's said Health Canada has completed screening and accepted the new drug submission under priority review for lanadelumab.

Lanadelumab, also known as SHP643, is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema, a rare, genetic disorder characterized by recurrent episodes of severe swelling in the limbs, face, intestinal tract and airway.

Health Canada's priority review will shorten the assessment timeline for Lanadelumab to 180 days from 300 days.

Additionally, the European Medicines Agency validated its marketing authorization application for the drug. Shire said the validation confirms that the submission is sufficiently complete and an accelerated assessment of the potential therapy will begin.

In February, the EMA's Committee for Medicinal Products for Human Use granted an accelerated assessment for the drug, reducing the number of evaluation days required to 150 days from 210 days.

Shire said the filings are supported by data from its four clinical trials. In a phase 3 trial, called HELP, treatment with the drug resulted in an 87% reduction in the mean frequency of hereditary angioedema attacks compared to placebo.

Lanadelumab also received priority review from the U.S. Food and Drug Administration and priority review and orphan drug designation from the Therapeutic Goods Administration in Australia.

The FDA is expected to provide a decision by Aug. 26.

On March 28, Takeda Pharmaceutical Co. Ltd. said it was considering making a potential takeover bid for the Irish drugmaker, noting that the consideration is at a "preliminary and exploratory stage" and that the company has not reached out to Shire's board.