Pharmexa receives orphan drug status for GV1001 for pancreatic cancer in the US
FDA has granted orphan drug status to Pharmexa for the peptide vaccine GV1001 for the treatment of pancreatic cancer.
Orphan drug status is granted in the United States to drugs aimed at diseases affecting less than 200,000 people in the United States. Orphan drug status in the United States provides opportunities for a closer dialogue with the health authorities through the development process, reduced fees and certain other benefits, as well as 7 years of market exclusivity following drug approval. GV1001 already has orphan drug status in Europe for the same indication.
Jakob Schmidt, CEO in Pharmexa says: "Already now, receiving orphan drug status in the US gives us an advantage in our further planning of the US part of the phase III programme for GV1001. In the longer term, having orphan drug status in US and Europe gives us a significant advantage in connection with the future commercialization of this drug and as such it increases the value of our program within pancreatic cancer."
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