Novartis dealt another Galvus setback

Share this article:

Newly discovered liver safety problems with high doses of Novartis' diabetes treatment Galvus are expected to delay the European launch of the drug and have raised questions about whether the FDA will back its approval here in the US.

Data showed that patients taking 100 mg doses of Galvus once daily had more frequent liver-enzyme elevation when compared to those taking 50 mg a day or 50 mg twice daily.

Novartis has recommended changing doses to 50 mg once or twice daily rather than the single higher dose.

The company said it plans to discuss the data with regulators.

Galvus has been approved for use in the European Union but analysts predict the new findings could push back its launch there for at least three to six months.

Meanwhile, skin toxicity issues have dogged Galvus' US approval. Novartis aims to resubmit the drug in the US in 2009.

The delays are a further setback for Novartis as Merck's Januvia continues to gain market share as the only DPP-4 inhibitor on the market.

DPP-4s, such as Januvia and Galvus, are designed to enhance the body's own ability to lower elevated blood sugar.

Januvia won US marketing approval in October 2006.

 

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...