Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links
PHARMA - ANEMIA TREATMENT AND HEART FAILURE 

Anemia drug darbepoetin's late-stage studies begin: Amgen

 

BY OUR PHARMA CORRESPONDENT

8 September, 2005: Late-stage studies to evaluate the effect of anemia treatment with darbepoetin alfa on morbidity and mortality in patients with heart failure, has been begun by Amgen.

The randomized, placebo-controlled, double-blind, multicenter trials will be conducted at different geographical locations, Amgen announced in a press release.

Numerous epidemiological studies have consistently demonstrated that lower hemoglobin values, reflecting a condition known as anemia, are associated with increased hospitalizations and mortality in heart failure patients. "These studies have generated a very strong hypothesis that if you raise hemoglobin values with darbepoetin alfa, you can improve outcomes in this patient population. This landmark trial will test this important hypothesis, the release noted.

The Executive Committee for this phase 3 trial will be co-chaired by Karl Swedberg, professor of Medicine at Sahlgrenska University Hospital/Ostra-Goteborg University in Sweden.

According to the American Heart Association, approximately five million Americans and over four million Europeans suffer from heart failure. Over twenty three million suffer from heart failure worldwide. Heart failure is the leading cause of hospitalization for people over the age of 65 years and causes almost one million hospitalizations each year. This condition results in decreased oxygen delivery to the body due to a poorly functioning heart. Anemia reduces the oxygen content of the blood. When both heart failure and anemia occur together, oxygen delivery is further hampered, leading to a worsened condition for the patient. Although anemia is a common condition in heart failure patients, physicians caring for them have typically overlooked anemia in the absence of definitive studies suggesting that it should be treated.

Results from Amgen's phase 2 pilot studies of anemia in heart failure patients will be released in early 2006. More information about Amgen's Phase 3 trial in heart failure is available at www.amgentrials.com.
Darbepoetin alfa (Aranesp) is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the development of a recombinant erythropoietin, epoetin alfa, which is currently marketed in the U.S. by Amgen as Epogen (Epoetin alfa) and by Ortho Biotech Products, LP, as Procrit (Epoetin alfa.) Building on this heritage, Amgen developed Aranesp, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule, resulting in more activity, with the added benefit of less-frequent administration.

Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, the drug was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies.

Aranesp is contraindicated in patients with uncontrolled hypertension and patients with known hypersensitivity to the active substance or any of the excipients. Erythropoietic therapies may increase the risk of thrombotic and other serious events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any two-week period. The most commonly reported side effects in the trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.

The drug dosage should be adjusted for each patient to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Doses must be individualized to ensure that hemoglobin is maintained at an appropriate level for each patient.

A biotechnology pioneer since 1980, Amgen develops treatments to fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. 

BY OUR PHARMA CORRESPONDENT

Pharma News Headlines

Cancer News

Cardiac News

US FDA News

Pharma industry news

Diseases - Alzheimer's, Parkisonson's and Obesity

Contraception and Abortion News

LATEST UPDATES

Anti fungal terbinafine launched in Europe: Actavis

HIV entry blocking drug data encouraging: Progenics

Allegra generic to be launched in US

Long-acting pain drug data positive: Pain Therapeutics

New kidney cancer drug seeks EU nod

Inhaled insulin may get US FDA clearance

A vaccine against fungus is on way

Enzyme stops progression of HIV in survivors, confirms study

Aclasta found faster-acting in Paget's disease treatment

Beta blocker can start therapy in heart failure: Merck

Halobetasol generic launched in US

Anemia drug darbepoetin's late-stage studies begin: Amgen

Cholesterol generic gets marketing nod in US: Par

Aricept for severe Alzheimer’s disease too: Eisai

Bone regeneration trials begin in US:Mesoblast

New dye to detect early Alzheimer's

Breast forming gene discovered

Thyroid drug to be supplied by IVAX in US

Rituxan, cancer drug can treat rheumatoid arthritis

Yasminelle, low-dose oral contraceptive approved in the Netherlands

Fluarix, anti-flu shot by Glaxo approved

Increlex, drug to treat `abnormally short’ kids approved in US

Anti-HIV drugs prices cut: Gilead

US FDA approves Takeda’s drug combo for type 2 diabetes

Novartis’ drug for breast cancer recurrence to be given priority review in US

US puts off decision on contraceptive pill again

Shire’s ADHD drug Adderall back on list in Canada

WHO calls for emergency action to halt TB in Africa

Some of the Vioxx suits may be settled: Merck

Nasdaq delists Able on bankruptcy filing

Hospira ships ceftriaxone generics to US

Renovis stops sciatica drug studies

Merck sets up generic arm Genpharm in US

Morning after pills still not within easy reach in US

New cancer combo therapy results positive:OXiGENE

Aceon approved for heart disease treatment in US

Cell Therapeutics to seek approval for lung cancer therapy in US and Europe

Anti-depressant Seroxat defended by GSK against new findings

Vioxx verdict: Merck’s defeat to trigger thousands of lawsuits from US, UK

Aspirin stops colon cancer, but may trigger bleeding

New blood test method approved in US

Skin disease drug turns into anti-tumor therapy for cancer

Step-by-Step instructions for dealing with Asthma Attacks

Potential Alzheimer's Disease drugs under investigation

New Molecule may help obese lose weight

Paxil (Paroxetine) may heighten suicide risks, finds study

"Breast cancer chances higher due to fried chips"

Safety alert on Gambro Dasco’s Prisma renal system

Merck responsible for Vioxx death: Jury

Heart disease deaths more among New Yorkers

Pfizer to offer drugs risk/benefit summary to consumers 

Merck lied to public on Vioxx: lawyer tells jurors

Novartis acquires rights of kidney dialysis drug from SeBo

J&J's Concerta approved treatment of ADHD in teenagers in Canada

US FDA stalls Roche’ Accutane use in pregnancy

Novo Nordisk, Eli Lilly remove insulin products from Australia

British drug supply chain safety questioned after another fake Lipitor find

Wyeth starts support programme for Effexor patients

P&G’s Actonel with Calcium approved for osteoporosis

Pozen gets patent on pain management product

Genmab studies new drug for rheumatoid arthritis

Painkillers may increase blood pressure: study

Nektar buys out Aerogen for $32 m

Predix records positive data on anxiety drug

Insmed files against Increlex approval

Hepatitis A vaccine for kids approved in US

Psoriasis drug data positive: Cytochroma

Novo Nordisk’s 24-hour acting insulin Levemir gets US FDA okay

US FDA approves Teva's generic for osteoporosis 

 

Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Latest updates    Contact Us - Feedback    About Us