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Bristol-Myers Squibb reported on Nov. 2 that the Food and Drug Administration would need more time to review ipilimumab, its biologic drug for melanoma.
The agency was due to make an approval decision by Dec. 25, but now will have until March 26, 2011, according to a statement from Bristol-Myers.
The drug maker said that it submitted additional data to the FDA at the agency’s request.
Ipilimumab, to be marketed as Yervoy, was also due to be reviewed by the FDA’s Oncologic Drugs Advisory Committee on Dec. 2. That meeting is now in doubt, said Ira Loss of "Washington Analysis," a research and analysis company, in an interview.
"I've seen this happen enough times in the past where the product is scheduled on a panel, the company submits additional data, the PDUFA [user fee] date gets pushed out, and then they dropped the meeting," said Mr. Loss.
He still expects approval for ipilimumab, in part because he believes the data are strong, and because "there hasn't been any other product approved for melanoma in years," he said.
In its statement, the drug maker said, "Bristol-Myers Squibb continues to be very encouraged by its interactions with the FDA and remains confident in the overall development program for ipilimumab."
The company noted that "ipilimumab is also currently under review with the European Medicines Agency and other health authorities worldwide."
Bristol-Myers Squibb reported on Nov. 2 that the Food and Drug Administration would need more time to review ipilimumab, its biologic drug for melanoma.
The agency was due to make an approval decision by Dec. 25, but now will have until March 26, 2011, according to a statement from Bristol-Myers.
The drug maker said that it submitted additional data to the FDA at the agency’s request.
Ipilimumab, to be marketed as Yervoy, was also due to be reviewed by the FDA’s Oncologic Drugs Advisory Committee on Dec. 2. That meeting is now in doubt, said Ira Loss of "Washington Analysis," a research and analysis company, in an interview.
"I've seen this happen enough times in the past where the product is scheduled on a panel, the company submits additional data, the PDUFA [user fee] date gets pushed out, and then they dropped the meeting," said Mr. Loss.
He still expects approval for ipilimumab, in part because he believes the data are strong, and because "there hasn't been any other product approved for melanoma in years," he said.
In its statement, the drug maker said, "Bristol-Myers Squibb continues to be very encouraged by its interactions with the FDA and remains confident in the overall development program for ipilimumab."
The company noted that "ipilimumab is also currently under review with the European Medicines Agency and other health authorities worldwide."
Bristol-Myers Squibb reported on Nov. 2 that the Food and Drug Administration would need more time to review ipilimumab, its biologic drug for melanoma.
The agency was due to make an approval decision by Dec. 25, but now will have until March 26, 2011, according to a statement from Bristol-Myers.
The drug maker said that it submitted additional data to the FDA at the agency’s request.
Ipilimumab, to be marketed as Yervoy, was also due to be reviewed by the FDA’s Oncologic Drugs Advisory Committee on Dec. 2. That meeting is now in doubt, said Ira Loss of "Washington Analysis," a research and analysis company, in an interview.
"I've seen this happen enough times in the past where the product is scheduled on a panel, the company submits additional data, the PDUFA [user fee] date gets pushed out, and then they dropped the meeting," said Mr. Loss.
He still expects approval for ipilimumab, in part because he believes the data are strong, and because "there hasn't been any other product approved for melanoma in years," he said.
In its statement, the drug maker said, "Bristol-Myers Squibb continues to be very encouraged by its interactions with the FDA and remains confident in the overall development program for ipilimumab."
The company noted that "ipilimumab is also currently under review with the European Medicines Agency and other health authorities worldwide."