U.S. Rejects Novartis Painkiller

By Hans Schoemaker and Jeanne Whalen

Novartis AG said the U.S. Food and Drug Administration rejected its painkiller Prexige in a decision that had been expected after the drug was withdrawn from the Australian market due to side effects.

U.S. Unlikely To Approve Novartis Drug

By Anita Greil

Novartis AG chief executive Daniel Vasella said he doesn't expect the company's painkiller Prexige to gain U.S. approval. The drug was pulled from the Australian market earlier this year on safety concerns.
"If you want my personal opinion, I don't expect we'll get approval," Mr. Vasella told investors attending an event in East Hanover, N.J., to showcase the Switzerland-based company's portfolio of drugs.

Australia recalls anti-inflammatory drug Prexige after two deaths

Sat Aug 11, 3:41 PM ET
Australia's drugs watchdog said Saturday it had ordered the recall of the anti-inflammatory medication Prexige after it was linked to two deaths.
The Therapeutic Goods Administration (TGA) said Australia was the first country to withdraw the drug, which is in the same class of pharmaceuticals as Vioxx, withdrawn by manufacturer Merck in 2004.
Technically called lumiracoxib, Prexige is produced by the Switzerland-based company Novartis AG, which said it had contacted health authorities in 50 countries where the drug is sold about the withdrawal.
The move followed a review of eight cases where people suffered severe liver damage after using the drug. Two of those people died and another two required liver transplants.
"As a result of those case reports we have taken this straight to our drug safety committee who met yesterday," said Rohan Hammett, the TGA's principal medical adviser.
"They recommended that it immediately be deregistered."
Australia was the first country to recall the drug, Hammett said.
Prexige is taken by about 60,000 people in Australia and is prescribed for osteoarthritis, post-operative pain, pain related to dental procedures and painful menstruation.
The TGA has recommended people taking Prexige seek an alternative medication and have liver function blood tests. It is a non-steroidal anti-inflammatory drug, technically called a Cox-2 inhibitor.
Another Cox-2 inhibitor, Vioxx or Rofecoxib, was voluntarily recalled by manufacturer Merck in 2004 due to adverse health conditions in patients taking it.
"Regulators around the world have been watching this class of drugs very closely since Vioxx and hence we've acted very quickly," Hammett said.
Novartis said it supported the decision.
"Cleary, patient safety is of the utmost importance," said Nick Kurstjens, the company's chief scientific officer for Australia.

Australia recalls anti-inflammatory drug Prexige after two deaths

Sat Aug 11, 3:31 AM ET
Australia's drugs watchdog said Saturday it had ordered the recall of the anti-inflammatory medication Prexige after it was linked to two deaths.
The Therapeutic Goods Administration (TGA) said Australia was the first country to withdraw the drug, which is in the same class of pharmaceuticals as Vioxx, withdrawn by manufacturer Merck in 2004.
Technically called lumiracoxib, Prexige is produced by the Switzerland-based company Novartis AG, which said it had contacted health authorities in 50 countries where the drug is sold about the withdrawal.
The move followed a review of eight cases where people suffered severe liver damage after using the drug. Two of those people died and another two required liver transplants.
"As a result of those case reports we have taken this straight to our drug safety committee who met yesterday," said Rohan Hammett, the TGA's principal medical adviser.
"They recommended that it immediately be deregistered."
Australia was the first country to recall the drug, Hammett said.
Prexige is taken by about 60,000 people in Australia and is prescribed for osteoarthritis, post-operative pain, pain related to dental procedures and painful menstruation.
The TGA has recommended people taking Prexige seek an alternative medication and have liver function blood tests. It is a non-steroidal anti-inflammatory drug, technically called a Cox-2 inhibitor.
Another Cox-2 inhibitor, Vioxx or Rofecoxib, was voluntarily recalled by manufacturer Merck in 2004 due to adverse health conditions in patients taking it.
"Regulators around the world have been watching this class of drugs very closely since Vioxx and hence we've acted very quickly," Hammett said.
Novartis said it supported the decision.
"Cleary, patient safety is of the utmost importance," said Nick Kurstjens, the company's chief scientific officer for Australia.

Novartis's Prexige seen better for blood pressure

By Ben Hirschler2 hours, 44 minutes ago
Novartis AG's Prexige painkiller is significantly better for blood pressure than older generic drug ibuprofen, researchers said on Friday.
High blood pressure affects around 40 percent of people with osteoarthritis, for which ibuprofen is widely used and Prexige has been approved in some countries. The joint disease is generally seen among elderly people, who are more likely to suffer from hypertension.
Data presented at the annual European Congress of Rheumatology showed patients with osteoarthritis who were already taking blood pressure pills had a slight decrease in hypertension on Prexige, compared with a slight increase in those taking ibuprofen.
Novartis shares rose 1.2 percent to 69.20 Swiss francs by 0851 GMT.
Both drugs belong to a class of medicines called non-steroidal anti-inflammatory drug, or NSAIDs, but Prexige is a more selective agent known as a COX-2 inhibitor.
COX-2s have been under a cloud since the withdrawal of Merck & Co. Inc.'s Vioxx in 2004 after studies found it raised heart-attack risk, and there have also been worries about other NSAIDs.
Tom MacDonald, professor of clinical pharmacology at Ninewells Hospital & Medical School in Dundee, Scotland, said the new findings were encouraging in view of these safety concerns.
"NSAIDs, including some COX-2s, have been associated with raised blood pressure, and this effect may be in part responsible for the increased risk of cardiovascular disease associated with this class of medications," he said.
AWAITING U.S. VERDICT
Prexige is approved in more than 50 countries -- and is currently being rolled out in Europe -- but it has yet to win a green light in the United States, the world's biggest market.
The drug had initially been seen as a blockbuster product for Novartis, but analysts' expectations for its sales collapsed following the Vioxx withdrawal, and there were doubts whether Prexige would ever win U.S. approval.
Karl Heinz Koch of Swiss brokerage Vontobel said the new results supported the safety profile of Prexige in the tarnished COX-2 drug class and gave Prexige a better chance of U.S. approval than Arcoxia, a follow-up COX-2 drug from Merck that was voted down by a Food and Drug Administration panel.
If approved, Prexige could yet sell $1 billion a year, Koch said, though given the controversy over COX-2s, he is not including U.S. sales in his financial forecasts for now.
The four-week placebo-controlled study presented in Barcelona looked at results from a total of 741 patients, aged 50 or older, and compared 100 milligrams of Prexige given once daily with 600 mg ibuprofen taken three times daily.
At the end of the study, Prexige patients showed a decrease in mean systolic blood pressure of 2.7 millimeters of mercury (mmHg) versus a 2.2 mmHg increase in those on ibuprofen. Diastolic blood pressure decreased by 1.5 mmHg in the Prexige group and rose 0.5 mmHg in those taking ibuprofen.
Systolic pressure represents the pressure within blood vessels when the heart contracts, while diastolic pressure is measured between heart beats.