Roche eye drug debate moves into patient rooms
Thu, May 5 2011
By Julie Steenhuysen
CHICAGO (Reuters) - Doctors say new data give them more confidence that the cheaper drug Avastin works as well as Lucentis in treating blindness from macular degeneration, but they will need to spend more time explaining potential risks.
The debate over the drugs, both made by Roche Holding AG, moves into clinical practice after a federally funded study showed last week the two were equally effective. It also raised some safety questions about Avastin, which was designed to treat cancer.
While it is still early, some expect more patients will pick Avastin.
Dr. Paul Sternberg of the Vanderbilt Eye Institute in Nashville, who has no ties with Roche or partner Novartis AG, said he does not plan to change treatment for existing Lucentis patients, but conversations with new patients will be different.
"Before I would say there are two drugs available, but one is FDA-approved (for this use). Now I will say there are two drugs that are available ... and say the effectiveness is comparable and the cost is certainly different, but there is still some question about safety," he said.
"I cannot tell you the treatment choice will be different, but my guess is that the percentage of patients who opt for Avastin will be greater," he said.
Results of the 1,200 patient study by the National Eye Institute, part of the National Institutes of Health, were released last week in the New England Journal of Medicine and on Sunday at the Association for Research in Vision and Ophthalmology meeting in Florida.
The study, dubbed CATT, showed the two drugs worked equally well when used over a four-week period to prevent vision loss in patients with the wet form of age-related macular degeneration.
Avastin is not approved for wet AMD, but doctors have used it for years as a much cheaper alternative, costing just $50 per dose compared with $2,000 per dose of Lucentis.
A shift to Avastin could means billions in lost sales to Roche and Novartis, which generated around $1.5 billion each in Lucentis sales last year. Some analysts see it becoming a $10 billion-plus drug.
"There was a widespread clinical consensus that Avastin seemed to be working as well as Lucentis. However, in an evidence-based world, you'd like to have a study that actually confirms that. We now have that study," said Dr. George Williams, chair of ophthalmology at Beaumont Hospitals in Royal Oak, Michigan, and a spokesman for the American Academy of Ophthalmology.
But the study also showed that more patients treated with Avastin wound up in the hospital than those who took Lucentis, 24 percent versus 19 percent.
"It is certainly not definitive proof that Avastin has a higher side- effect profile, but it is a signal," Williams said in a telephone interview.
POTENTIAL SAFETY SIGNAL
Some 13 million Americans have signs of AMD -- the leading cause of blindness in people over 60 -- and more than 1 million Americans have the wet form, the most severe type.
In wet AMD, abnormal blood vessels grow beneath the retina and leak blood and fluid. Both Lucentis and Avastin are vascular endothelial growth factor, or VEGF, inhibitors that work by blocking the growth of blood vessels.
Adding to concern over Avastin's safety is an analysis of more than 77,000 Medicare claims led by a team at Johns Hopkins University and Roche's Genentech unit presented on Tuesday.
A summary of the results released before the meeting showed Avastin increased the risk of death by 11 percent and the risk of stroke by 57 percent compared with Lucentis.
Novartis on Wednesday said the analysis was the biggest yet comparing the two drugs and said the findings add to existing evidence that the risk of death and stroke may be higher in patients treated with Avastin rather than Lucentis.
"Now more than ever, it is clear that Lucentis and Avastin are different, and Novartis believes Lucentis is the best treatment option for patients," said Trevor Mundel, global head of development at Novartis Pharma.
But Dr. Emily Gower of Johns Hopkins, who led the study, said in an email the rate of these side effects was extremely low. "The difference in risk of hemorrhagic stroke we found in the first analysis is a difference of 1.5 events per 1,000 person years -- a very rare event," she said.
She said a secondary analysis showed no significant difference in these side effects.
"Which analysis is the 'truth' remains unclear," she said.
Gower, who has no financial ties with Genentech, said her study does not prove that one drug is better than another -- only that more study is needed.
Last week, Gower and researchers at Genentech met with lawmakers and officials at Medicare to go over the findings, raising some eyebrows over her relationship with the company.
But Gower rejected any suggestion that she was working on behalf of the company to advance the case that Avastin was riskier than Lucentis.
"I received no compensation for these interactions with Congressional staffers and others. It was not my intent to advance the interests of the companies but rather to provide an accurate report of this research."
Sternberg said that because the Gower study was funded by Genentech, there is some skepticism.
"I'd like the opportunity to truly see the data. I'd like it to have peer review before I am willing to embrace these conclusions," he said.
Gower said scientists will get that chance, as she plans to submit the data to a peer-reviewed medical journal.
And more studies are on the way. In Britain, results are expected in the second half of this year from the smaller 600-patient IVAN study backed by the country's National Institute for Health Research comparing Lucentis and Avastin.
(Additional reporting by Ben Hirschler in London; Editing by Michele Gershberg and Gerald E. McCormick)
Thu, May 5 2011
By Julie Steenhuysen
CHICAGO (Reuters) - Doctors say new data give them more confidence that the cheaper drug Avastin works as well as Lucentis in treating blindness from macular degeneration, but they will need to spend more time explaining potential risks.
The debate over the drugs, both made by Roche Holding AG, moves into clinical practice after a federally funded study showed last week the two were equally effective. It also raised some safety questions about Avastin, which was designed to treat cancer.
While it is still early, some expect more patients will pick Avastin.
Dr. Paul Sternberg of the Vanderbilt Eye Institute in Nashville, who has no ties with Roche or partner Novartis AG, said he does not plan to change treatment for existing Lucentis patients, but conversations with new patients will be different.
"Before I would say there are two drugs available, but one is FDA-approved (for this use). Now I will say there are two drugs that are available ... and say the effectiveness is comparable and the cost is certainly different, but there is still some question about safety," he said.
"I cannot tell you the treatment choice will be different, but my guess is that the percentage of patients who opt for Avastin will be greater," he said.
Results of the 1,200 patient study by the National Eye Institute, part of the National Institutes of Health, were released last week in the New England Journal of Medicine and on Sunday at the Association for Research in Vision and Ophthalmology meeting in Florida.
The study, dubbed CATT, showed the two drugs worked equally well when used over a four-week period to prevent vision loss in patients with the wet form of age-related macular degeneration.
Avastin is not approved for wet AMD, but doctors have used it for years as a much cheaper alternative, costing just $50 per dose compared with $2,000 per dose of Lucentis.
A shift to Avastin could means billions in lost sales to Roche and Novartis, which generated around $1.5 billion each in Lucentis sales last year. Some analysts see it becoming a $10 billion-plus drug.
"There was a widespread clinical consensus that Avastin seemed to be working as well as Lucentis. However, in an evidence-based world, you'd like to have a study that actually confirms that. We now have that study," said Dr. George Williams, chair of ophthalmology at Beaumont Hospitals in Royal Oak, Michigan, and a spokesman for the American Academy of Ophthalmology.
But the study also showed that more patients treated with Avastin wound up in the hospital than those who took Lucentis, 24 percent versus 19 percent.
"It is certainly not definitive proof that Avastin has a higher side- effect profile, but it is a signal," Williams said in a telephone interview.
POTENTIAL SAFETY SIGNAL
Some 13 million Americans have signs of AMD -- the leading cause of blindness in people over 60 -- and more than 1 million Americans have the wet form, the most severe type.
In wet AMD, abnormal blood vessels grow beneath the retina and leak blood and fluid. Both Lucentis and Avastin are vascular endothelial growth factor, or VEGF, inhibitors that work by blocking the growth of blood vessels.
Adding to concern over Avastin's safety is an analysis of more than 77,000 Medicare claims led by a team at Johns Hopkins University and Roche's Genentech unit presented on Tuesday.
A summary of the results released before the meeting showed Avastin increased the risk of death by 11 percent and the risk of stroke by 57 percent compared with Lucentis.
Novartis on Wednesday said the analysis was the biggest yet comparing the two drugs and said the findings add to existing evidence that the risk of death and stroke may be higher in patients treated with Avastin rather than Lucentis.
"Now more than ever, it is clear that Lucentis and Avastin are different, and Novartis believes Lucentis is the best treatment option for patients," said Trevor Mundel, global head of development at Novartis Pharma.
But Dr. Emily Gower of Johns Hopkins, who led the study, said in an email the rate of these side effects was extremely low. "The difference in risk of hemorrhagic stroke we found in the first analysis is a difference of 1.5 events per 1,000 person years -- a very rare event," she said.
She said a secondary analysis showed no significant difference in these side effects.
"Which analysis is the 'truth' remains unclear," she said.
Gower, who has no financial ties with Genentech, said her study does not prove that one drug is better than another -- only that more study is needed.
Last week, Gower and researchers at Genentech met with lawmakers and officials at Medicare to go over the findings, raising some eyebrows over her relationship with the company.
But Gower rejected any suggestion that she was working on behalf of the company to advance the case that Avastin was riskier than Lucentis.
"I received no compensation for these interactions with Congressional staffers and others. It was not my intent to advance the interests of the companies but rather to provide an accurate report of this research."
Sternberg said that because the Gower study was funded by Genentech, there is some skepticism.
"I'd like the opportunity to truly see the data. I'd like it to have peer review before I am willing to embrace these conclusions," he said.
Gower said scientists will get that chance, as she plans to submit the data to a peer-reviewed medical journal.
And more studies are on the way. In Britain, results are expected in the second half of this year from the smaller 600-patient IVAN study backed by the country's National Institute for Health Research comparing Lucentis and Avastin.
(Additional reporting by Ben Hirschler in London; Editing by Michele Gershberg and Gerald E. McCormick)