Multiple Choice Elan
Members of an FDA administration panel in Maryland listen to a discussion on Tysabri
Thursday April 6th 2006
WITH a June deadline looming for Federal Drug Administration (FDA) clearance for Elan's multiple sclerosis treatment Tysabri, all eyes are on the Irish drugmaker.
US regulators recently delayed a decision on Tysabri's return by as much as 90 days because it's reviewing the companies' plan to prevent a rare side effect that killed two patients.
Earlier, a decision had been expected by March 29.
The drug was removed from the market after two patients died from a rare brain infection called PML.
But Elan is upbeat about the outcome and anticipates regulatory action by the FDA on or before June.
Lars Ekman, Elan executive director and president of global R&D, said that the recent unanimous vote by the FDA Advisory Committee to recommend reintroduction of Tysabri, as a treatment for relapsing forms of MS, is a very positive step forward in the company's ongoing efforts to bring Tysabri back to patients living with MS.
"The patients spoke loudly and clearly that they would like Tysabri back as a treatment alternative, so that they can exercise their right to make informed choices."
Indeed, the whole Tysabri debacle has again raised the debate as to whether individuals themselves should be able to decide whether or not to trial drugs.
Lobby groups, especially bodies in the US like MS Patients for Choice, have been very vocal in the case of Tysabri.
Writing in the 'Washington Times', Henry Miller, a physician and fellow at the Hoover Institution and Competitive Enterprise Institute, said that regulators' increasing sensitivity to safety may have become contagious: Drug manufacturers, too, seem to have begun to "err on the side of safety" to a degree that triggers voluntary removal from the market of safe and effective drugs.
"Consider Tysabri, only the sixth medication approved - and the first in several years - for treating MS, a debilitating autoimmune disease affecting the central nervous system."
He added that this ray of hope was short-lived and that by the time several thousand patients were being treated with Tysabri, three confirmed cases of a rare neurological disorder caused by a virus were reported.
"Immediately - some say prematurely - the medicine's manufacturers voluntarily halted production and distribution and withdrew Tysabri from the market."
But Mr Miller argues that we tolerate more uncertainty and severe side effects for a potential cure for pancreatic cancer or Aids than for treating heartburn.
"When the FDA grants marketing approval, the drug is deemed safe and effective for conditions on the label."
According to Dr Orla Hardiman, consultant neurologist at Beaumont Hospital, Dublin, the FDA has a very important role to play although it can be "quite bureaucratic".
She added that there is a long history of lobby groups in relation to new drugs and this was a big issue in the 1980s with Aids treatments.
"Sometimes these groups take on a lifeforce of their own.
"In many cases, they raise people's expectations and there are also concerns that lobby groups have their own agendas."
She added that in the case of Tysabri, the drug only works on certain types of MS, and only early on in the disease.
From an Elan perspective, the company said that it is committed to working with the FDA to provide responsible commercial access to those patients suffering from this debilitating condition.
"We are in ongoing discussions with the agency to finalise a prudent risk management plan that does not overburden the MS patients or their physicians," said Mr Ekman.
He added that Elan is continuing with clinical trials and commercial preparations and to ensure that we are able to launch Tysabri soon after we receive approval from the FDA.
Apart from the medical side of the story, there is a whole other group awaiting the outcome of the latest FDA delay - the investor.
Shareholders in Elan have had a stressful time over the past year with the share price see-sawing almost weekly.
Some analysts expect Tysabri to reach annual sales of more than $3bn if the safety concerns do not cause the Federal Drug Administration (FDA) to restrict access to the product.
However, they will have to sit it out until June before there is any real outcome.
© http://www.unison.ie/
http://www.unison.ie/business/stories.php3?ca=80&si=1593451&printer=1
Thursday April 6th 2006
WITH a June deadline looming for Federal Drug Administration (FDA) clearance for Elan's multiple sclerosis treatment Tysabri, all eyes are on the Irish drugmaker.
US regulators recently delayed a decision on Tysabri's return by as much as 90 days because it's reviewing the companies' plan to prevent a rare side effect that killed two patients.
Earlier, a decision had been expected by March 29.
The drug was removed from the market after two patients died from a rare brain infection called PML.
But Elan is upbeat about the outcome and anticipates regulatory action by the FDA on or before June.
Lars Ekman, Elan executive director and president of global R&D, said that the recent unanimous vote by the FDA Advisory Committee to recommend reintroduction of Tysabri, as a treatment for relapsing forms of MS, is a very positive step forward in the company's ongoing efforts to bring Tysabri back to patients living with MS.
"The patients spoke loudly and clearly that they would like Tysabri back as a treatment alternative, so that they can exercise their right to make informed choices."
Indeed, the whole Tysabri debacle has again raised the debate as to whether individuals themselves should be able to decide whether or not to trial drugs.
Lobby groups, especially bodies in the US like MS Patients for Choice, have been very vocal in the case of Tysabri.
Writing in the 'Washington Times', Henry Miller, a physician and fellow at the Hoover Institution and Competitive Enterprise Institute, said that regulators' increasing sensitivity to safety may have become contagious: Drug manufacturers, too, seem to have begun to "err on the side of safety" to a degree that triggers voluntary removal from the market of safe and effective drugs.
"Consider Tysabri, only the sixth medication approved - and the first in several years - for treating MS, a debilitating autoimmune disease affecting the central nervous system."
He added that this ray of hope was short-lived and that by the time several thousand patients were being treated with Tysabri, three confirmed cases of a rare neurological disorder caused by a virus were reported.
"Immediately - some say prematurely - the medicine's manufacturers voluntarily halted production and distribution and withdrew Tysabri from the market."
But Mr Miller argues that we tolerate more uncertainty and severe side effects for a potential cure for pancreatic cancer or Aids than for treating heartburn.
"When the FDA grants marketing approval, the drug is deemed safe and effective for conditions on the label."
According to Dr Orla Hardiman, consultant neurologist at Beaumont Hospital, Dublin, the FDA has a very important role to play although it can be "quite bureaucratic".
She added that there is a long history of lobby groups in relation to new drugs and this was a big issue in the 1980s with Aids treatments.
"Sometimes these groups take on a lifeforce of their own.
"In many cases, they raise people's expectations and there are also concerns that lobby groups have their own agendas."
She added that in the case of Tysabri, the drug only works on certain types of MS, and only early on in the disease.
From an Elan perspective, the company said that it is committed to working with the FDA to provide responsible commercial access to those patients suffering from this debilitating condition.
"We are in ongoing discussions with the agency to finalise a prudent risk management plan that does not overburden the MS patients or their physicians," said Mr Ekman.
He added that Elan is continuing with clinical trials and commercial preparations and to ensure that we are able to launch Tysabri soon after we receive approval from the FDA.
Apart from the medical side of the story, there is a whole other group awaiting the outcome of the latest FDA delay - the investor.
Shareholders in Elan have had a stressful time over the past year with the share price see-sawing almost weekly.
Some analysts expect Tysabri to reach annual sales of more than $3bn if the safety concerns do not cause the Federal Drug Administration (FDA) to restrict access to the product.
However, they will have to sit it out until June before there is any real outcome.
 Members of an FDA administration panel in Maryland listen to a discussion on Tysabri |
 |
© http://www.unison.ie/
http://www.unison.ie/business/stories.php3?ca=80&si=1593451&printer=1
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