Thursday September 27, 06:33 AM
Novartis painkiller Prexige rejected by FDA; continues talks with regulator
ZURICH (Thomson Financial) - Novartis AG (Virt-X: NOVN.VX - news) said its painkiller Prexige (Lumiracoxib) has been rejected by the US Food and Drug Administration (FDA) but added that it will continue talks with the regulator on possible approval of the drug for patients with higher rates of gastrointestinal and osteoarthritic problems.
'We believe Prexige remains an important therapy for appropriate patients...and we will continue discussions with the FDA,' said James Shannon, head of development at Novartis' pharma division in a company statement.
The FDA said it remains 'open to exploring the use of this medicine in patients where Prexige would provide an acceptable benefit-to-risk balance,' according to Novartis.
The Swiss pharma group warned in September that the chances of US approval for Prexige were very low 'given the current environment'.
In August, the painkiller was banned in Australia after two patients died of liver complications and two more had to undergo liver transplants. Novartis said the majority of patients affected were on 200 mg doses and one on 400 mg.
Australia was at the time the only country in the world allowing 200 mg doses of Prexige, double the amount generally recommended today.
Prexige is approved in more than 50 countries, said Novartis, adding that it has submitted an alternative trade name for US regulatory approval.
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