By Colin Kellaher 
 

Merck KGaA (MRK.XE) on Monday said the U.S. Food and Drug Administration granted orphan-drug designation to the bifunctional immunotherapy M7824 for the treatment of biliary tract cancer.

The Darmstadt, Germany, maker of pharmaceuticals and chemicals said biliary tract cancer is a collective term for a group of rare and aggressive gastrointestinal cancers, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for a seven-year marketing exclusivity period against competition.

Merck said about 16,000 cases of biliary tract cancer occur in the U.S. each year and present late in the majority of patients.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 10, 2018 10:37 ET (15:37 GMT)