Liver problems delay Galvus launch
pharmafile | November 9, 2007 | News story | Sales and Marketing |Â Â reg, safetyÂ
The European launch of new diabetes drug Galvus could be delayed by up to six months after small but significant doubts emerged over its safety.
A new analysis of clinical data showed a potentially dangerous liver side effect was more common in the higher 100-mg dose of Novartis' new drug.
The company has taken the unusual step of asking the European regulator to revise already approved prescribing information before the drug is launched. It wants to effectively withdraw Galvus 100-mg once-a-day tablets, relying instead on a once or twice a day 50mg dose.
Analysts estimate findings from the data could delay the launch of Galvus in Europe by three to six months, as the pharma company and regulator work out a new final label for the product.
The new analysis of clinical trial data from over 8,000 patients revealed a very small proportion (less than 1%) had raised liver enzymes on the 100mg dose which could cause damage to the organ, but even such relatively small doubts could undermine the drug's future.
The company says the incidence of raised liver enzymes in the 50-mg daily dose of Galvus was comparable to that seen in older drugs metformin, a glitazone or a sulfonylurea.
The diabetes market is in flux after one of the most prescribed oral treatments, GSK's Avandia, was linked with raised cardiovascular risk. Novartis had positioned Galvus as being as least as effective as Avandia, and free of weight gain seen in this drug, but its liver doubts has already undermined this claim.
The delay and safety doubts will also give Merck's Januvia more time to establish itself. Januvia is in the same new class as Galvus, but has been free of safety concerns so far.
Galvus is already on the market in Brazil and Mexico as both a 50-mg and 100-mg daily dose. In the vital US market, the FDA has not yet approved Galvus, giving it an 'approvable letter' but demanding further data to clarify its safety profile.
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