EMEA approves patupilone for the treatment of primary peritoneal cancer and fallopian tube cancer
Committee for Orphan Medicinal Products adopted opinions for designation of 13 medicines as orphan medicinal products
The European Medicines Agency (EMEA) Committee for Orphan Medicinal Products (COMP) held its 104th plenary meeting on 1-2 September 2009. During the meeting, members of the Committee elected the new Chairperson and the Vice-Chairperson for a term of three years. Dr Kerstin Westermark (Sweden) was elected as Chairperson, and Mrs Birthe Byskov Holm (Patient Representative nominated by the European Commission) was elected as Vice-Chairperson.
The COMP adopted 13 positive opinions recommending the following medicines for designation as orphan medicinal products to the European Commission:
- Patupilone for treatment of primary peritoneal cancer, Novartis Europharm Limited.
- Patupilone for treatment of fallopian tube cancer, Novartis Europharm Limited.
The review began on 5 June 2009 with an active review time of 90 days.
For the following anti-cancer medicines the EMEA review began on 10 July 2009 with an active review time of 55 days.
- 5'-O-(trans-9''-octadecenoyl)-1-beta-D-2'deoxy-2',2'-difluorocytidine for treatment of pancreatic cancer, Clavis Pharma ASA.
- Anti-EphA2 monoclonal antibody conjugated to maleimidocaproyl monomethylauristatin phenylalanine for treatment of ovarian cancer, MedImmune Ltd.
- Masitinib mesilate for treatment of pancreatic cancer, AB Science.
- N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino]isonicotinamide
- hydrochloride for treatment of pancreatic cancer, Merck KGaA.
- NGR-human tumour necrosis factor for treatment of hepatocellular carcinoma, MolMed S.p.A.
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