Novartis gets FDA Breakthrough Therapy tag for experimental iptacopan
Novartis gets FDA Breakthrough Therapy tag for experimental iptacopan
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.
FILE PHOTO: The company’s logo is seen at the new cell and gene therapy factory of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann/File Photo
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.
Reporting by John Miller; editing by Thomas Seythal
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