The Committee for Orphan Medicinal Products of the European Medicines
Agency (EMA) has granted orphan drug designation to CellAct Pharma’s
CAP7.1, an adapted version of the well-established anticancer agent
etoposide, for the treatment of biliary tract cancers. European
Union(EU) orphan drug designation is given to products for the
diagnosis, prevention or treatment of rare diseases that are
life-threatening or very serious. A disease is defined as rare in the EU
if it affects fewer than five in 10,000 people.
Biliary tract cancer affects approximately 1.7 in 10,000 people in the EU. This is equivalent to a total of around 87,000 people. The granting of EU orphan drug designation provides CellAct with development and commercial incentives, including a 10-year period of market exclusivity, access to a centralised review process, protocol assistance and scientific advice during product development, waiving or reduction of certain fees, and eligibility for grants and R&D support initiatives.
CellAct is currently recruiting patients for a randomised, multicentre, proof-of-concept phase 2 study with CAP7.1in adults with refractory biliary tract carcinomas in Germany (www.cap7-1.com).
Biliary tract cancer affects approximately 1.7 in 10,000 people in the EU. This is equivalent to a total of around 87,000 people. The granting of EU orphan drug designation provides CellAct with development and commercial incentives, including a 10-year period of market exclusivity, access to a centralised review process, protocol assistance and scientific advice during product development, waiving or reduction of certain fees, and eligibility for grants and R&D support initiatives.
CellAct is currently recruiting patients for a randomised, multicentre, proof-of-concept phase 2 study with CAP7.1in adults with refractory biliary tract carcinomas in Germany (www.cap7-1.com).
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