March 27, 2012 — The US Food and Drug Administration (FDA) today announced it has approved the new erythropoiesis-stimulating agent (ESA) peginesatide to treat anemia in patients receiving dialysis who have chronic kidney disease (CKD).
Peginesatide, which was developed by Affymax in partnership with Takeda Pharmaceutical Co, will be marketed as Omontys. It works by stimulating the bone marrow to produce more red blood cells, thus increasing hemoglobin levels and reducing the need for transfusions in patients with CKD.
Injected subcutaneously once a month, the new anemia drug is expected to be a robust rival to epoetin alfa (Epogen, Amgen Inc). Affymax may also price peginesatide more competitively, which will be an advantage in an era of streamlined healthcare costs.
"Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections."
In December 2011, an FDA advisory panel voted 15 to 1, with a single abstention, in favor of approval, agreeing that the drug's benefits outweighed its risks in patients receiving dialysis.
The approval was based on 2 randomized, active-controlled, open-label, multicenter clinical trials involving 1608 patients with CKD who were receiving dialysis. Patients with hemoglobin levels initially stabilized by an ESA were randomly assigned either to receive peginesatide once monthly or to continue their current ESA (epoetin) treatment.
The study results showed that peginesatide safely and effectively maintained hemoglobin levels within the studies' prespecified range of 10 to 12 g/dL compared with epoetin.
The most common adverse effects, seen in 10% or more of patients receiving dialysis and treated with peginesatide, were diarrhea, vomiting, hypertension, and arthralgia.
"Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer-related anemia," according to the FDA news release. "It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis."
"It's always good to have competition in the healthcare industry. To have a medication available that can be used on a once-monthly basis is great," Jeffrey S. Berns, MD, professor of medicine and pediatrics at Perelman School of Medicine at the University of Pennsylvania, Philadelphia, told Medscape Medical News.
Cost a Major Factor
Dr. Berns said that peginesatide's infiltration into the market will be determined to a large extent by cost, as well as by preexisting contractual arrangements that dialysis providers may have with Amgen.
"If they have a prior commitment to use Epogen, for instance, that's going to limit use of a new agent for some period of time," he said. "Selling the [new] drug for less will obviously have a big impact. Now that dialysis providers have some skin in the game, as they say, with bundling [payments] in the US, there is going to be some pressure to find an equally effective, equally safe, but less expensive approach to anemia management."
Once-a-month administration will also reduce in-center costs, Dr. Berns predicted.
"Drug-related cost issues aside, there is some potential cost of having to administer the medication 3 times a week," Dr. Berns pointed out. "Staffing costs would not necessarily be reduced, because you still have the nurses to pay, but there is a small cost of syringes, drawing them up, needles, and all that sort of thing," he said. "If it is priced correctly, there certainly is going to be motivation to use it."
Rajiv Agarwal, MD, professor of medicine at Indiana University School of Medicine in Indianapolis, agrees that cost will be an important factor in determining peginesatide's popularity.
"Since the ESAs have become a cost center for most of the US dialysis units, if peginesatide is priced more competitively than the existing ESAs, this might actually increase its adoption," he told Medscape Medical News.
He also agrees that peginesatide's major benefit over the other ESAs is that it can be dosed once a month.
"I think this is a conceptual advantage over some of the other drugs because titration sometimes takes much longer, or needs to be done more frequently, than the package insert tells us," he said.
The hemoglobin response may take as long as 3 weeks, and clinicians often become impatient, Dr. Agarwal added.
"We jump the gun and change the dose of the drug. Peginesatide, because it is administered only once a month, can cause a significant advantage because you can then dose the drug less frequently and titrate less often."
Dr. Berns has disclosed no relevant financial relationships. Dr. Agarwal has been a consultant for Takeda, Affymax and Amgen.
Peginesatide, which was developed by Affymax in partnership with Takeda Pharmaceutical Co, will be marketed as Omontys. It works by stimulating the bone marrow to produce more red blood cells, thus increasing hemoglobin levels and reducing the need for transfusions in patients with CKD.
Injected subcutaneously once a month, the new anemia drug is expected to be a robust rival to epoetin alfa (Epogen, Amgen Inc). Affymax may also price peginesatide more competitively, which will be an advantage in an era of streamlined healthcare costs.
"Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections."
In December 2011, an FDA advisory panel voted 15 to 1, with a single abstention, in favor of approval, agreeing that the drug's benefits outweighed its risks in patients receiving dialysis.
The approval was based on 2 randomized, active-controlled, open-label, multicenter clinical trials involving 1608 patients with CKD who were receiving dialysis. Patients with hemoglobin levels initially stabilized by an ESA were randomly assigned either to receive peginesatide once monthly or to continue their current ESA (epoetin) treatment.
The study results showed that peginesatide safely and effectively maintained hemoglobin levels within the studies' prespecified range of 10 to 12 g/dL compared with epoetin.
The most common adverse effects, seen in 10% or more of patients receiving dialysis and treated with peginesatide, were diarrhea, vomiting, hypertension, and arthralgia.
"Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer-related anemia," according to the FDA news release. "It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis."
"It's always good to have competition in the healthcare industry. To have a medication available that can be used on a once-monthly basis is great," Jeffrey S. Berns, MD, professor of medicine and pediatrics at Perelman School of Medicine at the University of Pennsylvania, Philadelphia, told Medscape Medical News.
Cost a Major Factor
Dr. Berns said that peginesatide's infiltration into the market will be determined to a large extent by cost, as well as by preexisting contractual arrangements that dialysis providers may have with Amgen.
"If they have a prior commitment to use Epogen, for instance, that's going to limit use of a new agent for some period of time," he said. "Selling the [new] drug for less will obviously have a big impact. Now that dialysis providers have some skin in the game, as they say, with bundling [payments] in the US, there is going to be some pressure to find an equally effective, equally safe, but less expensive approach to anemia management."
Once-a-month administration will also reduce in-center costs, Dr. Berns predicted.
"Drug-related cost issues aside, there is some potential cost of having to administer the medication 3 times a week," Dr. Berns pointed out. "Staffing costs would not necessarily be reduced, because you still have the nurses to pay, but there is a small cost of syringes, drawing them up, needles, and all that sort of thing," he said. "If it is priced correctly, there certainly is going to be motivation to use it."
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Dr. Rajiv Agarwal
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"Since the ESAs have become a cost center for most of the US dialysis units, if peginesatide is priced more competitively than the existing ESAs, this might actually increase its adoption," he told Medscape Medical News.
He also agrees that peginesatide's major benefit over the other ESAs is that it can be dosed once a month.
"I think this is a conceptual advantage over some of the other drugs because titration sometimes takes much longer, or needs to be done more frequently, than the package insert tells us," he said.
The hemoglobin response may take as long as 3 weeks, and clinicians often become impatient, Dr. Agarwal added.
"We jump the gun and change the dose of the drug. Peginesatide, because it is administered only once a month, can cause a significant advantage because you can then dose the drug less frequently and titrate less often."
Dr. Berns has disclosed no relevant financial relationships. Dr. Agarwal has been a consultant for Takeda, Affymax and Amgen.
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