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:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and ... Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD ... that can be easily incorporated into liquid products, while reducing costs to end users. ...
(Date:10/13/2017)... OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... or dementia. However, many long-term care insurance companies have a waiver for care if ... the 90-day elimination period, when the family pays for care, is often waived, so ...
(Date:10/13/2017)... Texas (PRWEB) , ... October 13, 2017 , ... Yisrayl ... this week that explains one of the most popular and least understood books in ... like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the ... “America On The Brink” is the creation of published author, William Nowers. Captain ... As a WWII veteran, he spent thirty years in the Navy. Following his ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... products to meet the demand of today’s consumer and regulatory authorities worldwide. From ... probiotic experts and tested to meet the highest standard. , These products ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... Sept. 25, 2017   Montrium , an ... solutions, today—from the IQPC Trial Master Files & ... NL)—announced that EastHORN Clinical Services has selected ... and TMF management. EastHORN, a leading European contract ... to increase transparency to enable greater collaboration with ...
(Date:9/19/2017)... medical device company developing a non-invasive, robotically assisted, platform therapy that uses pulsed sound energy ... ... Jim Bertolina, PhD ... Tom Tefft ... executive Josh Stopek , PhD, who has led R&D and business development teams at ...
(Date:9/12/2017)... , Sept. 12, 2017   EcoVadis , the leading platform for ... the first annual edition of its Global CSR Risk and Performance Index. ... by EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data points ... ... ...
Breaking Medicine Technology:
Cached News: