NVS Novartis AG

   By Alberto Delclaux 
 

Novartis AG (NOVN.EB) said Wednesday that the U.S. Food and Drugs Administration granted priority review designation to drug Promacta for first-line treatment of severe aplastic anemia, or SAA.

The priority review is based on data that shows that 52% of treatment-naive SAA patients achieved complete response at six months when treated with Promacta in combination with standard immunosuppressive therapy, Novartis said. This represents an increase of 35% compared to patients treated with the standard treatment alone, it added.

SAA is a rare, life-threatening that affects the production of blood cells. It is estimated that 500 to 1,000 SAA cases are diagnosed each year in the U.S., Novartis said.

Promacta is marketed as Revolade in most countries outside the U.S.

Write to Alberto Delclaux at alberto.delclaux@dowjones.com

(END) Dow Jones Newswires

May 30, 2018 01:51 ET (05:51 GMT)

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