HOME >> MEDICINE >> NEWS
European commission grants "orphan" status for new acute myeloid leukaemia treatment

Wyeth-Ayerst Pharmaceuticals, the pharmaceutical division of American Home Products Corporation (NYSE:AHP),announced today that the European Commission has designated Mylotarg(gemtuzumab ozogamicin)as an "orphan medicinal product." The Commission decision follows a positive opinion adopted on 13 September 2000 by the Committee on Orphan Medicinal Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).

"We anticipate that Mylotarg will become an important treatment option for European patients aged 60 and over with CD33-positive relapsed acute myeloid leukaemia (AML)," says L. Patrick Gage, Ph.D., President, Wyeth-Ayerst Research. "Its mechanism of action focuses on using antibody-antigen specificity to target delivery of potent chemotherapy to myeloid leukaemic cells. This compound represents the first product from Wyeth's promising oncology pipeline."

As a designated orphan medicinal product, Mylotarg will have access to the Commission's "centralised" procedure for assessment of the marketing authorisation application. Orphan medicinal products are intended to treat patients with rare life-threatening or very serious diseases for which no satisfactory method of treatment exists or where the product will be of significant benefit.

Orphan medicinal products do not automatically qualify for approval under "exceptional circumstances," but companies that sponsor orphan products receive incentives for bringing these products to the market and to the patient. Such incentives include the possibility of protocol assistance from the EMEA and fee reductions for all types of centralised marketing authorisation evaluation activities. If approved by the EMEA, Mylotarg would be the first product available in Europe from a new class of anticancer therapy known as "antibody-targeted chemotherapy." Mylotarg utilizes a patented linker technology with a novel potent anti-tumor antibiotic, calicheamicin.

Mylotarg is being develo
'"/>

Contact: Roseann Ward
roseann.ward@ketchumcomms.co.uk
44-0-207-465-8752
Ketchum
14-Nov-2000


Page: 1 2 3

Related medicine news :

1. ESC releases the first European Guidelines on Percutaneous Coronary Interventions (PCI)
2. The European Society of Cardiology launches Women at Heart
3. Use of potentially inappropriate medications among elderly common in some European countries
4. European folic acid policies are not effective enough
5. New European cancer figures for 2004 major efforts needed against the big four killers
6. Third of European cancer patients use complementary and alternative therapies
7. A new service from the European Patent Office
8. European study highlights persistent 3 decade increase in childhood cancer incidence
9. European nations urged to ratify international treaty on tobacco control
10. Increased investment in radiotherapy will improve cure rates for European cancer patients
11. ESA looking for more European women to volunteer for WISE bed-rest study in Toulouse next year

Post Your Comments:
(Date:4/17/2014)... status as the leading weapon against the deadly disease ... new research indicating it simply needs to be administered ... the cheap anti-malarial drug chloroquine in treating and preventing ... than half a million people each year around the ... resistance to chloroquine, but research carried out at the ...
(Date:4/16/2014)... Calif. Consider the marvel of the embryo. It begins ... function as they multiply to become the cells of our ... the body. , Now, in a feat of reverse tissue ... genetic coding that allows embryonic cells to proliferate and transform ...
(Date:4/16/2014)... HAMPTON, NJ (April 16, 2014): Celldex Therapeutics, Inc. ... Phase 1 study of CDX-1401 in solid tumors, including ... Translational Medicine (Vol 6 Issue 232). The data ... of clinical benefit in patients with very advanced cancers ...
(Date:4/16/2014)... Ill. April 16, 2014 According to a ... in average-risk patients with one to two small polyps ... of cases. This may be an appropriate target for ... study to quantify adherence to guidelines for timing of ...
(Date:4/15/2014)... the United States have nearly doubled since 1988, suggests new ... with obesity apparently to blame for the surge. The researchers ... hit all groups equally, with alarming increases in diabetes in ... reported in the April 15, 2014 issue of the ...
Breaking Medicine News(10 mins):Health News:Scientists find new way to fight malaria drug resistance 2Health News:Stanford scientists develop 'playbook' for reverse engineering tissue 2Health News:Stanford scientists develop 'playbook' for reverse engineering tissue 3Health News:Celldex's Phase 1 study of CDX-1401 published in Science Translational Medicine 2Health News:Celldex's Phase 1 study of CDX-1401 published in Science Translational Medicine 3Health News:Celldex's Phase 1 study of CDX-1401 published in Science Translational Medicine 4Health News:Surveillance colonoscopy recommendations for average-risk patients with 1 to 2 small polyps consistent with guidelines 2Health News:Surveillance colonoscopy recommendations for average-risk patients with 1 to 2 small polyps consistent with guidelines 3Health News:Pre-diabetes and diabetes nearly double over the past 2 decades 2
(Date:1/15/2014)... MultiCell Technologies, Inc. (OTC Bulletin Board: ... concerning composition of matter, biological targets, mechanism of action, ... This patent application describes a novel ... (VSRNAs) which interfere with the basic homeostatic cellular processes ...
(Date:1/15/2014)... 2014 The Cadence Fitness & Health Center has ... Medical Fitness Association, a non-profit organization assisting medically integrated ... The Cadence Fitness & Health Center is the only ... in the Chicagoland area. "The certification means ...
(Date:1/15/2014)... Jan. 15, 2014 Reportlinker.com announces that ... in its catalogue: ... Analysis http://www.reportlinker.com/p01957812/Insulin-Pump-Market--Forecast-–-Worldwide-Analysis.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Equipment_and_Supply ... Insulin Pumps are gaining ...
Breaking Medicine Technology:MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Insulin Pump Market & Forecast - Worldwide Analysis 2Insulin Pump Market & Forecast - Worldwide Analysis 3Insulin Pump Market & Forecast - Worldwide Analysis 4Insulin Pump Market & Forecast - Worldwide Analysis 5Insulin Pump Market & Forecast - Worldwide Analysis 6Insulin Pump Market & Forecast - Worldwide Analysis 7Insulin Pump Market & Forecast - Worldwide Analysis 8Insulin Pump Market & Forecast - Worldwide Analysis 9Insulin Pump Market & Forecast - Worldwide Analysis 10Insulin Pump Market & Forecast - Worldwide Analysis 11Insulin Pump Market & Forecast - Worldwide Analysis 12Insulin Pump Market & Forecast - Worldwide Analysis 13Insulin Pump Market & Forecast - Worldwide Analysis 14Insulin Pump Market & Forecast - Worldwide Analysis 15Insulin Pump Market & Forecast - Worldwide Analysis 16Insulin Pump Market & Forecast - Worldwide Analysis 17
Cached News: