Australia bans Novartis' Prexige

Another one bites the dust: Australia's drug regulators have banned the Novartis drug Prexige because of severe liver-related side effects, including two deaths--possibly a third--and two transplants. Patients were advised to stop taking Prexige, a COX-2 inhibitor, immediately. Novartis said it would comply with the authority's decision but that it felt the benefits of Prexige still outweigh its risks.

The drug isn't yet approved for use in the U.S. and Novartis says it still intends to apply to market Prexige here. However, Prexige is already facing an uphill battle because of the COX-2 taint; Prexige is only the latest in a series of COX-2 inhibitors to fall under post-market scrutiny. And the Australian's ban is another link in a chain of pain for Novartis, which had to withdraw its bowel drug Zelnorm in March.

- read the report from the Sydney Morning Herald
and here's the AFX report

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.