Surprise delay for Novartis’ Galvus
pharmafile | November 15, 2006 | News story | Sales and Marketing |Â Â Galvus, diabetesÂ
The FDA will take three months longer than expected to review Novartis' new diabetes treatment, Galvus, after the pharma company submitted new safety data.
Galvus had been in a close race to market with Merck's recently approved Januvia and the delay raises the possibility Novartis' product faces a more restrictive label than its rival.
Novartis Pharma's head of development James Shannon said: "We are confident of the efficacy and safety of Galvus and in gaining US approval.
"We believe this additional information being provided to the FDA will strengthen the already robust data supporting Galvus as a new and needed treatment option for patients with type II diabetes."
Novartis says the new data confirms that skin problems identified in a single species during pre-clinical animal testing have not been seen in clinical studies of type II diabetes patients.
Galvus (vildagliptin) and Januvia (sitagliptin) are the most advanced products in the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of treatments for type II diabetes. These work by enhancing the body's ability to lower elevated blood sugar levels and use a different mechanism of action from any of the currently available glucose-lowering agents.
The FDA wrote to a number of companies developing DPP-4 treatments in November 2005 and earlier this year, requesting more information on the three-month primate studies relating to these skin problems, which were not seen in any other species, including humans.
The request was triggered following reports of skin toxicity in primates from an unknown DPP-4 drug, which was not Galvus, Januvia or GlaxoSmithKline's Redona (denagliptin), according to analysts Lehman Brothers.
Other companies working on developing drugs in the class include Bristol Myers (saxaglitpin) and Takeda (SYR322) and the analysts say it is not clear whether either of these firms, or another company, prompted concern at the FDA.
The regulator will now scrutinise Novartis' data on skin toxicity before coming to a decision on Galvus by February 2007 and the delay could put the product at a disadvantage against Januvia.
Merck has stated that their primate toxicity studies did not show any skin toxicity. This raises concerns that Novartis' Galvus, even if approved, may suffer from a detrimental label, the analysts said in a research note.
Merck's Januvia is set to be the first DPP-4 product to come to market after it received FDA approval in October as a monotherapy and as an add-on treatment with either metformin or a thiazolidinedione.
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