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:
*Name:
*Comment:
*Email:


(Date:8/21/2019)... ... August 21, 2019 , ... Calling all Veterans ... Palliative Care’s Veterans and First Responders Recognition Ceremony on Wednesday, September 11 at ... all branches of the military and law enforcement are expected to attend. , ...
(Date:8/21/2019)... ... ... ISOComforter , a leader in providing products for cold therapy pain relief , ... powered cold unit supply that is shaped like a small cooler. A long ... as the shoulder pad, lumbar pad, hip wrap, or knee pad. , ISOComforter has changed ...
(Date:8/19/2019)... ... August 19, 2019 , ... Nearly seven years after the ... , the authorized retailer will change its corporate name to ‘EmStore.com’. , In ... providing Eminence Organic Skin Care facials and treatments. DeVries noticed there was an ...
(Date:8/19/2019)... Calif. (PRWEB) , ... August 19, 2019 , ... A ... suggests that dog owners should be brushing their pets’ teeth twice a day. The ... not have the time and suggests that close monitoring and brushing at least twice ...
(Date:8/17/2019)... ... August 17, 2019 , ... Inc. Magazine Unveils YellowTelescope, ... 5000 , For the 2nd Year In a Row, YellowTelescope LLC Appears on ... , Inc. magazine today revealed that YellowTelescope LLC (YellowTelescope, SEOversite, and iScreamSocialMedia) is ...
Breaking Medicine News(10 mins):
(Date:8/17/2019)... ... August 17, 2019 , ... The American Legion Dorchester ... (VA) Maryland Health Care System for the benefit of veteran patients, adding to a ... month ago. , This most recent donation from Post 91 will enable ...
(Date:8/16/2019)... ... August 16, 2019 , ... A new medical device for ... that both corrects the curve and maintains flexibility in the spine. , The ... by medical staff of Shriners Hospitals for Children® — Philadelphia. It is the ...
(Date:8/16/2019)... (PRWEB) , ... August 16, 2019 , ... ... first Houston Care Fair for residents of Houston, TX including Montrose, Heights, Memorial ... 2019 at SignatureCare Emergency Center in Houston Heights, is aimed at helping Houston ...
Breaking Medicine Technology:
Cached News: