Galvus Receives European Approval
Novartis (NYSE:NVS) has received a positive opinion for their diabetes drug Galvus from European health authorities after the drug maker made changes to prescribing recommendations amid liver-safety concerns. Galvus which is still awaiting approval in the U.S. is from the class of drugs as Januvia from Merck (NYSE:MRK) which has recently undergone a label change regarding concerns of a potentially dangerous form of skin cancer.
With Avandia basically gone from the marketplace due to cardiovascular concerns, Januvia has been able to build a strong presence in the market as physicians look for a credible replacement. Merck has positioned Januvia as an oral form of Byetta, although the drugs lacks the efficacy and weight loss results shown by Byetta. Based on patient and physician interviews Januvia appears to work best when used in combination with metformin. Now that Byetta has been approved for uses a monotherapy it will be interesting to see if Januvia continues to build share.
Diabetic Investor suspects both Januvia and Byetta will benefit from Avandia’s troubles. Also helping both drugs is the lack of competitors in late stage clinical trials. While there are several intriguing drugs in early stage trials it remains to be seen if these drugs will make it to market. The most promising late stage drug is the once-a-week version of Byetta which according to Amylin (NASDAQ:AMLN) should be submitted to the Food and Drug Administration (FDA) sometime in early 2009, possibly late 2008.
Given the concerns of liver safety and skin lesions Diabetic Investor does not see the FDA quickly following the Europeans lead and approving Galvus in the near future. It is also difficult to gauge what impact Galvus would have on Januvia even if approved. Januvia has a huge lead and has already established itself with physicians. Novartis faces an uphill battle which makes this one small piece of good news a rather hollow victory.