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:9/4/2015)... Pass, OR (PRWEB) , ... September 04, 2015 ... ... that markets a line of personal humidifying medical devices, announced its only mission ... climate, explains Bio-Logic Aqua® Research Founder Sharon Kleyne, body water evaporation is becoming ...
(Date:9/4/2015)... ... September 04, 2015 , ... The ... place in Hollywood, Florida October 9-10, 2015 at the Diplomat Resort & Spa ... symposium are doctors and researchers at the top of their field and will ...
(Date:9/4/2015)... ... 2015 , ... ECC announces the site selection and commencement ... with intellectual, developmental and acquired disabilities. The first community, named Luna Azul, will ... homes. In this community, adults will live safely and permanently in homes owned ...
(Date:9/4/2015)... (PRWEB) , ... September 04, 2015 , ... ... the Benker Residence in South Glastonbury, Connecticut, has been selected for the Residential ... of significant energy efficiency and resiliency measures. Chosen from a highly competitive field ...
(Date:9/4/2015)... ... September 04, 2015 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has ... involving the Pope’s upcoming trip to the United States. , Yisrayl lays out what he ... the Vatican and society is. Yisrayl also provides the meaning of his own name and ...
Breaking Medicine News(10 mins):Health News:Bio-Logic Aqua® Research Announces Water Life Science and Body Water Evaporation as Research Focus and Mission 2Health News:Bio-Logic Aqua® Research Announces Water Life Science and Body Water Evaporation as Research Focus and Mission 3Health News:Integrative Healthcare Symposium Focus On: The Microbiome Conference Program Announced 2Health News:Cottage Home Communities for Disabled Adults to Create First Viable Permanent Housing Option 2Health News:Cottage Home Communities for Disabled Adults to Create First Viable Permanent Housing Option 3Health News:Cottage Home Communities for Disabled Adults to Create First Viable Permanent Housing Option 4Health News:South Glastonbury Home Selected for Award by Connecticut Green Building Council 2Health News:Yisrayl Hawkins Writes Open Letter to Pope Francis In Light of Approaching U.S. Visit 2
(Date:9/3/2015)... Sept. 3,  2015 About artificial ... devices, which are implanted or integrated into ... These include artificial heart, kidney, pancreas, and ... (polyurethane, polysulfone, and porous polypropylene), biologics, ceramics, ... organs. These organs are incorporated with different ...
(Date:9/3/2015)... 3, 2015 This Defibrillators are critical life ... of lives across globe. This report provides in-depth analysis ... Saudi Arabia . Stakeholders for this report include ... and regulatory bodies. The Saudi Arabia ... by products and by end users. In terms of ...
(Date:9/3/2015)... 3, 2015 Nevro Corp. (NYSE: NVRO ... innovative evidence-based solutions for the treatment of chronic pain, ... the Morgan Stanley Global Healthcare Conference on Thursday, September ... Nevro management is scheduled to present at 11:45 a.m. ... audio webcast, accessible in the "Investors" section of the ...
Breaking Medicine Technology:Global Artificial Organ Market 2015-2019 2Saudi Arabia Defibrillators Market: & Advanced Life Support Defibrillators; End Users; Industry Analysis, Size, Volume, Growth, Trends and Forecast 2014 - 2020 2
Cached News: