Bad News and Good New for Novartis
Within a period of 2 days, Novartis has suffered a loss in the US and scored a victory in Europe.
On 27 Sept 2007, the USFDA disapproved the COX-2 inhibitor Prexige (lumiracoxib). The drug is indicated for the treatment of osteoarthritis. Although marketed in many countries, the FDA is not fully convinced of the drug’s benefit-risk balance even after submission of additional safety data [1].
On the positive side, Galvus (vildagliptin) was granted marketing approval in the EU on 28 Sept 2007. Glavus is an oral DPP-4 inhibitor indicated for Type 2 diabetes. The centralised procedure marketing license is valid in 27 EU countries and the two EFTA countries Norway and Iceland.
It is not smooth sailing for Galvus in the US, either. Its approval in the US is delayed this year due to safety issues concerning patients with renal impairment. New clinical trials are ongoing to resolve these issues.[2].
[1] Novartis Media Release, 27 Sept 07. Prexige® receives ‘’not approvable'’ letter in the US despite being one of the most studied COX-2 inhibitors.
[2] Novartis Media Release, 28 Sept 07. Galvus® receives European approval as new treatment for type 2 diabetes with broad range of indications.
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