Are DPP - 4 inhibitors safe in Diabetics??
After FDA asked Novartis to run another study for their DPP-4 inhibitor Galvus(Vildagliptin), concerns raised about the safety profile of other DPP-4 inhibitor in market.
According to a APs press release "FDA seeks more data on new Novartis drug", US FDA has demanded additional data from Novartis before approving their new DPP-4 inhibitor, of diabetes drug. Dipeptidyl peptidase-4 inhibitors act mainly by preventing the rapid degradation of glucagon-like peptide-1.
Novartis said the regulatory body wants more information, including a clinical study in patients with kidney impairment, before giving Galvus its approval. The decision is a blow for the drugmaker because Galvus belongs to a new family of diabetes medicines that Novartis hopes will become strong earners for the company.
Before the start itself Novartis’s Galvus had a drawback over its counterpart Merck’s Januvia. Vildagliptin or Galvus has to be taken twice daily compared to the once daily dosage of Januvia. It may affect the compliance.
That means, Merck will enjoy its market share of Januvia (Sitagliptin) for some more time. At the same time it also has to keep an eye on any possible adverse events. If one DPP-4 inhibitor raises safety concern why not the other from the same group? We don’t need another Vioxx story. Do we??
Also Novartis has got the approval to market Galvus in Mexico.
Good to know about Vildagliptine.
If vildagliptine is under FDA scanner for concerns of safety in kidney failure,so should be sitagliptine (which is already there in market) before its large-scale use.In fact with Sitagliptine dose reduction is recommended in kidney failure.
Tinni
Seeji says
@ Tinni
Thank you for visiting my blog.
David Nathan published an article in NEJM Feb issue about the newer treatments in Diabetes. Go through that article http://content.nejm.org/cgi/content/short/356/5/437
This delay is indeed a huge loss to Novartis.. Currently DPP-4 inhibitors have more than $ 1 billion market in US.
Seeji.