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

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:10/9/2015)... ... October 09, 2015 , ... Head Over Heels Athletic ... elite developmental camp at the Karolyi Ranch in Huntsville, Texas on October 17-21. ... Over Heels girls team head coach and executive director, said. “It's a stepping stone ...
(Date:10/9/2015)... , ... October 09, 2015 , ... On Saturday, September ... World Jump Rope Championship in Madrid, Spain. Representing both the USA and Sweden in ... Double Unders and One-Minute Am Front Crosses, she was awarded 1 Silver and 4 ...
(Date:10/9/2015)... ... October 09, 2015 , ... Confidence Plus Insurance has ... community improvement initiative that involves working with a series of local charities throughout ... Confidence Plus Insurance is the Gleason Park Electric Violin Ensemble (GPEVE). , GPEVE ...
(Date:10/9/2015)... ... October 09, 2015 , ... "As a nurse, I care for male ... "They have to wear large diapers or pads. We came up with this as ... to absorb urine leaking from the tip of the penis. This prevents stains from ...
(Date:10/9/2015)... ... October 09, 2015 , ... MMJ PhytoTech ... with Ed Begley Jr., airing 1st QT 2016 via the Discovery Channel. Dates ... MMJ Phytotech Limited (MMJ) – a global leader in the field of commercializing ...
Breaking Medicine News(10 mins):
(Date:10/9/2015)... Lilly and Company (NYSE: LLY ) and Locemia ... Locemia,s intranasal glucagon, a potential treatment for severe hypoglycemia ... which is currently in Phase III clinical trial testing, ... hypoglycemia. --> --> ... formulation that is delivered in an emergency situation using ...
(Date:10/9/2015)... CHAPEL HILL, N.C. , Oct. 9, 2015 ... Pharmaceutical or Medical Device environments, corporate communications is ... external communications, corporations and professionals must continuously adjust ... the effectiveness of these adjustments is difficult, but ... to today,s communication options. ...
(Date:10/9/2015)... Regulatory affairs groups within medical device organizations face ... --> These specialized groups are charged with ensuring that ... pertaining to the development and marketing of medical device products. ... on their own internal effectiveness and efficiencies to remain productive ... --> --> Optimal resourcing and staffing ...
Breaking Medicine Technology:
Cached News: