Alexion Pauses Enrollment for COVID-19 Study Testing Its Rare Blood-Disorder Drug

By Reuters Staff

January 15, 2021

(Reuters) - Alexion Pharmaceuticals Inc on Wednesday paused enrollment in a late-stage study testing its rare blood-disorder drug in adults with severe COVID-19 requiring mechanical ventilation.

The drug, Ultomiris, is an improved version of Alexion's other rare blood-disorder drug, Soliris. Britain's AstraZeneca Plc in December agreed to buy the drugmaker for $39 billion, hoping Ultomiris has a larger market potential.

The decision to pause enrollment was based on a recommendation from an independent data monitoring committee (IDMC), which highlighted the lack of data on the effectiveness of Ultomiris when added to existing standard of care, the company said.

The IDMC's recommendation was based on a pre-planned interim analysis of the main goal of the study, Alexion added.

"We are disappointed in this initial outcome, but plan to further analyze the data to identify potential subgroups who may benefit and to determine next steps," said John Orloff, Alexion's executive vice president.

Ultomiris brought in sales of $289.3 million in the third quarter.