Novartis Gets FDA Breakthrough Therapy Tag for Experimental Iptacopan

By Reuters Staff

December 17, 2020

ZURICH (Reuters) - Novartis got the U.S. Food and Drug Administration's Breakthrough Therapy tag for its experimental medicine iptacopan, which the Swiss drugmaker hopes wins approval to treat the rare blood disorder paroxysmal nocturnal hemoglobinuria.

Getting the tag could speed the review process for the medicine, Novartis said on Wednesday.

In addition, the company also got the FDA's Rare Pediatric Disease designation for the drug against C3 glomerulopathy, a group of conditions that also cause the kidneys to malfunction.