Orphan Designation Granted for Nanoparticle Albumin-bound Paclitaxel in Treatment of Pancreatic Cancer

The European Commission has granted orphan designation to nanoparticle albumin-bound paclitaxel, also known as Abraxane, for the treatment of pancreatic cancer, a serious and rare disease that affects a significant number of patients in the EU. This designation was granted on November 26, 2010, and is based on the criteria of the rarity of the condition and the existence of alternative methods of diagnosis and treatment. The medicine, already authorized for the treatment of breast cancer in several countries, including the EU, was not authorized for pancreatic cancer at the time of submission. The designation is not a marketing authorization, and demonstration of quality, safety, and efficacy is required before the product can be granted a marketing authorization.

Key Takeaways:

• The European Commission granted orphan designation to nanoparticle albumin-bound paclitaxel on November 26, 2010, for the treatment of pancreatic cancer (EU/3/10/809).
• The orphan designation was based on the criteria of the rarity of the condition and the existence of alternative methods of diagnosis and treatment.
• Pancreatic cancer is a serious and rare disease that affects over 10,000 people in the EU, with limited treatment options available.
• The medicine, Abraxane, was already authorized for the treatment of breast cancer in several countries, including the EU, at the time of submission.
• The designation is not a marketing authorization, and demonstration of quality, safety, and efficacy is required before the product can be granted a marketing authorization.
• The European Commission's Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on September 9, 2010, recommending the granting of the designation.
• The opinions on orphan medicinal product designations are based on the following three criteria: the seriousness of the condition, the existence of alternative methods of diagnosis and treatment, and either the rarity of the condition or insufficient returns on investment.

Statistics:

• Over 10,000 people in the EU are affected by pancreatic cancer (Source: EU regulation).
• The Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on September 9, 2010 (Source: EU regulation).
• Regulation (EC) No 141/2000 of December 16, 1999, is the source of the orphan designation criteria (Source: European Commission).

Sources:

• European Commission (2010) - Decision of the European Commission granting orphan designation to Abraxis BioScience Ltd for nanoparticle albumin-bound paclitaxel.
• Regulation (EC) No 141/2000 of December 16, 1999 (Source: European Commission).
• European Commission (2010) - Committee for Orphan Medicinal Products (COMP) positive opinion on September 9, 2010.