Dublin Core
Title
Federal Regulators to Begin Testing on Drug Believed to Fight AIDS Virus
Description
"Washington - Bristol Myers Squibb Co. took a crucial step Tuesday toward winning final federal approval for the promising AIDS drug DDI, earning praise from AIDS activists"...
Creator
Rebecca Kolberg
Source
University of Tennessee Daily Beacon
Publisher
Knoxville, Tenn. : University of Tennessee
Date
1991-04-04
Language
English
Coverage
New York (State)
Text Item Type Metadata
Text
Washington - Bristol Myers Squibb Co. took a crucial step Tuesday toward winning final federal approval for the promising AIDS drug DDI, earning praise from AIDS activists.
The New York-based pharmaceutical giant announced it has filed a new drug application - a major hurdle in the drug-approval process - for dideoxyinosine, known as DDI, with the Food and Drug Administration.
Bristol-Myers is making the drug available free to AIDS patients who have no other treatment options and who cannot take part in tests traditionally required for drug approval.
More than 17,000 people have received DDI through this expanded access program and another 2,300 got DDI in traditional tests, company officials said.
But AIDS activits contend even more patients would be able to get the drug if it were approved for general marketing and have called on the FDA to make a decision on DDI as quickly as possible.
Since March 1987, there has been only one government approved drug - AZT - to directly the AIDS virus. Both AZT and DDI work by interfering with an enzyme the virus needs to reproduce.
"It's high time that some other drugs came down the pipe... Let's hope it starts a price war," said Mark Harrington of the AIDS Coalition to Unleash Power in New York.
DDI is chemically similar to AZT, the name given the drug zidovudine, but appears to have different toxic side effects. Consequently, patients who cannot tolerate AZT may be able to take DDI.
Many patients have to stop taking AZT because of severe anemia and bone marrow suppression.
DDI has been associated with a potentially fatal inflammation of the pancreas and can trigger a painful nerve disorder in the hands and feet.
Brad Stone, an FDA spokesman, would not speculate how quickly DDI could be approved, but he noted it took only 3 months between the time AZT's new drug application was filed and when final approval was granted.
"We review any application for any AIDS drug as quickly as possible. But it is impossible to say how long it will take for DDI," Stone said.
In its application, Bristol-Myers Squibb asked for permission to market DDI under the tradename Videx for treating both children and adults who have symptoms stemming from infection with the AIDS causing human immunodeficiency virus.
Harrinton said he was please Bristol-Myers Squibb was pushing for a "broad indication" for DDI, not just recommending the drug only for people who cannot tolerate AZT.
Dr. Mervyn Silverman, president of the American Foundation for AIDS Research in New York, he said he was hopeful.
"We hope the (FDA review) will be expedited to the greatest degree possible and as many people as possible will benefit from this," he said.
Silverman said DDI probably will be priced more affordably than AZT, which costs about $10,000 annually per patient when it was first approved.
However, he said he does not expect DDI to push AZT off the shelves because the two drugs will most likely be used together in treatment strategies.
Susan Yarin, a Bristol-Myers Squibb spokeswoman, said about 3 percent of patients receiving DDI in tests developed inflammation of the pancreas, called pancreatitis.
Of the patients with DDI-linked pancreatitis, about 10 percent died in the first eight months of testing, but that death rate has sinces declined to about 5.4 percent, Yarin said.
Early tests of the drug showed it boosted levels of key immune cells, called T-4 cells, and promoted weight gain, Yarin said.
She refused to comment on results of later tests or predict when DDI might be approved or how much it might cost.
Dideoxycytidine, another experimental drug related to DDI, is at a similar stage of testing.
The AIDS Coalition to Unleash Power has charged that Nutley, N.J.-based Hoffman La Roche Inc., the maker of dideooxycytidine, is dragging its feet in providing the promising but unproven drug to people with the human immunodeficiency virus.
The New York-based pharmaceutical giant announced it has filed a new drug application - a major hurdle in the drug-approval process - for dideoxyinosine, known as DDI, with the Food and Drug Administration.
Bristol-Myers is making the drug available free to AIDS patients who have no other treatment options and who cannot take part in tests traditionally required for drug approval.
More than 17,000 people have received DDI through this expanded access program and another 2,300 got DDI in traditional tests, company officials said.
But AIDS activits contend even more patients would be able to get the drug if it were approved for general marketing and have called on the FDA to make a decision on DDI as quickly as possible.
Since March 1987, there has been only one government approved drug - AZT - to directly the AIDS virus. Both AZT and DDI work by interfering with an enzyme the virus needs to reproduce.
"It's high time that some other drugs came down the pipe... Let's hope it starts a price war," said Mark Harrington of the AIDS Coalition to Unleash Power in New York.
DDI is chemically similar to AZT, the name given the drug zidovudine, but appears to have different toxic side effects. Consequently, patients who cannot tolerate AZT may be able to take DDI.
Many patients have to stop taking AZT because of severe anemia and bone marrow suppression.
DDI has been associated with a potentially fatal inflammation of the pancreas and can trigger a painful nerve disorder in the hands and feet.
Brad Stone, an FDA spokesman, would not speculate how quickly DDI could be approved, but he noted it took only 3 months between the time AZT's new drug application was filed and when final approval was granted.
"We review any application for any AIDS drug as quickly as possible. But it is impossible to say how long it will take for DDI," Stone said.
In its application, Bristol-Myers Squibb asked for permission to market DDI under the tradename Videx for treating both children and adults who have symptoms stemming from infection with the AIDS causing human immunodeficiency virus.
Harrinton said he was please Bristol-Myers Squibb was pushing for a "broad indication" for DDI, not just recommending the drug only for people who cannot tolerate AZT.
Dr. Mervyn Silverman, president of the American Foundation for AIDS Research in New York, he said he was hopeful.
"We hope the (FDA review) will be expedited to the greatest degree possible and as many people as possible will benefit from this," he said.
Silverman said DDI probably will be priced more affordably than AZT, which costs about $10,000 annually per patient when it was first approved.
However, he said he does not expect DDI to push AZT off the shelves because the two drugs will most likely be used together in treatment strategies.
Susan Yarin, a Bristol-Myers Squibb spokeswoman, said about 3 percent of patients receiving DDI in tests developed inflammation of the pancreas, called pancreatitis.
Of the patients with DDI-linked pancreatitis, about 10 percent died in the first eight months of testing, but that death rate has sinces declined to about 5.4 percent, Yarin said.
Early tests of the drug showed it boosted levels of key immune cells, called T-4 cells, and promoted weight gain, Yarin said.
She refused to comment on results of later tests or predict when DDI might be approved or how much it might cost.
Dideoxycytidine, another experimental drug related to DDI, is at a similar stage of testing.
The AIDS Coalition to Unleash Power has charged that Nutley, N.J.-based Hoffman La Roche Inc., the maker of dideooxycytidine, is dragging its feet in providing the promising but unproven drug to people with the human immunodeficiency virus.
Original Format
Print Newspaper