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Cresp from Dr Reddy’s: long-acting anemia drug darbepoetin alfa (Aranesp) generic in India

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Tuesday, August 10, 2010, 11:06 This news item was posted in Biotech category and has 0 Comments so far.

Dr Reddy’s launches Cresp, low-cost version of long-acting anemia drug darbepoetin alfa (Aranesp) in India

Darbepoetin is a much longer-acting version of epoetin alfa which is used in the treatment of severe anaemia in chronic kidney conditions and cancer.

Cresp is the world’s first generic version of darbepoetin alpha in the world and the only darbepoetin alfa in India, claimed Dr Reddy’s in a press release announcing the approval of the drug.

Drug Controller general of India has given approval for Cresp for the treatment of anaemia due to chronic kidney disease and anaemia due to chemotherapy.

Darbepoetin alfa is a modified version of epoetin alfa (rHuEPO), which is engineered to have a longer half life, increasing (up to 3 times) the time it remains in the blood. This results in a reduced frequency of doses, providing a simpler and more convenient treatment option for patients and physicians as compared to treatment of anaemia with epoetin which is the current standard of care in India.

Dr. Reddy’s will be launching Cresp in both vials and prefilled syringes (PFS), a company press release said.

“Cresp will offer patients in India an improved treatment regimen at affordable pricing,” stated GV Prasad, vice-chairman and CEO, Dr Reddy’s.

The launch of Cresp by Dr Reddy’s is a significant step in redefining the treatment of anaemia in India and underscores our commitment to provide affordable and innovative medicines to patients in India, he added.

The launch of Cresp is a significant achievement, demonstrating once again our development capabilities in the area of biosimilars. Reditux, launched three years ago, was the first, and still the only biosimilar monoclonal antibody in the world. Cresp represents another important first as the only biosimilar Darbepoetin alfa in the world, according to Cartikeya Reddy, senior vice president and head of biologics, Dr Reddy’s.

Globally, darbepoetin is marketed by Amgen under the trade name Aranesp.

Darbepoetin was approved in September 2001 by the Food and Drug Administration for treatment of anemia in patients with chronic renal failure.

Darbepoetin alfa injection causes the bone marrow to produce red blood cells. If the body does not produce enough red blood cells, severe anemia can occur. This often occurs in people with chronic kidney failure whose kidneys are not working properly. Darbepoetin may be used for patients on kidney dialysis or for those not on dialysis. Anemia can also occur in people who are receiving chemotherapy to treat cancer

Bangalore-based Avesthagen is another Indian firm which is currently working on a generic version of darbepoetin alpha.

Avesthagen’s darbepoetin named Avdesp has already completed preclinical studies and is ready for cGMP manufacturing for conducting clinical trials in India.

Avesthagen plans to launch Avdesp — –a therapeutically equivalent generic version of darbepoetin alfa biosimilar of Amgen’s Aranesp — in India by end of 2010.

Avesthagen has already been given clearance from the Review Committee for Genetic Manipulation (RCGM) based on the data and conclusions on toxicity and efficacy study of Avdesp submitted.

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