Saxagliptin Approval: Finally, Competition for Merck’s Januvia

Published On: August 1st, 2009

Januvia The FDA just approved saxagliptin, a diabetes medicine that will be co-marketed by Bristol-Myers Squibb and AstraZeneca. The drug, which will be sold under the brand name Onglyza, is in a relatively new class, called DPP-4 inhibitors, that can be taken along with older diabetes drugs.

Until now, Merck’s Januvia has been the only drug in the class on the market in this country. But in late 2006, when Januvia was approved by the FDA, you wouldn’t have guessed that Merck would have the market to itself for so long. That it has is a sign of the tough safety scrutiny the FDA has given to many new drugs in recent years.

The 2006 WSJ story on Januvia’s approval noted that Galvus, a DPP-4 drug from Novartis, was also awaiting approval. But that drug was delayed, then delayed again, over safety concerns based on animal studies — and Novartis finally walked away from getting it approved here (it is approved in Europe).

Takeda submitted its own DPP-4 drug, alogliptin, back in 2007, but that drug also has yet to be approved by FDA — and a statement from Takeda in March of this year suggested that the company may need to gather more data for FDA because of broad concerns about cardiovascular risks for all diabetes drugs.

All these delays, of course, have been just fine for Merck. In the first quarter of this year, the company’s sales of Januvia were over $400 million.

Photo: Bloomberg News

STOP PANIC ATTACKS - A Natural Technique To Stop Panic Attacks and Anxiety Fast!

The technique I teach has been developed by me Joe Barry, a former sufferer of all too frequent panic attacks and GAD. I developed a completely natural approach to eliminating 100% of general anxiety and panic attacks. This may seem very hard to believe for someone who may have had this condition for some time but believe me the new information is now available to be free from anxiety. I will reveal the whole technique to you.

Did you know:

Infant mortality rates offer a vivid portrait of disparities in health. Even at birth, children from racial and ethnic minorities suffer worse health outcomes, including a notably higher rate of death

superlative : @Will_Hoe Ah me too! Your Country Needs You is on tomorrow!

2010-03-11T14:26:04Z - Reply - View Tweet
DanielChalke : Which country gave most generously to the Haitian disaster? http://bit.ly/dhx84A

2010-03-11T14:21:51Z - Reply - View Tweet
bevisbert : Paralympians take it higher: Like most athletes, cross-country skier and current adaptive-snowboarding world cham... http://bit.ly/bDto8q

2010-03-11T14:21:07Z - Reply - View Tweet
idhokido : don't blame the BRITISH if your fvcking country, music or way of life is not good as the BRITISH

2010-03-11T14:17:54Z - Reply - View Tweet
RUBAQ : RT @ArabCrunch Google?s Special Treatment to Palestine: The Only Country in the World that has Fre.. http://bit.ly/asmuRg

2010-03-11T14:17:46Z - Reply - View Tweet
TiberiusPacheco : Will land in Gods Country in 2 hrs..... http://myloc.me/4GztN

2010-03-11T14:11:01Z - Reply - View Tweet
ziibook : Nigeria: A country of many stories http://goo.gl/fb/qvoa #ziibook #news

2010-03-11T14:09:42Z - Reply - View Tweet

Multaq Approval Marks Comeback for Sanofi’s Heart Drug
Multaq, Sanofi-Aventis’s treatment for heart-rhythm disorders, has made a comeback . Rejected by the FDA in 2006 because of safety concerns, the agency has approved Multaq, the company announced today. The drug approval is the French drug maker’s first major U.S ..
Healthcare Reform’s Final Hurdles
The House and the Senate are each trying to hammer out details in order to pass health care bills before the August recess. But it’s a complicated and difficult process, Laura Meckler explains. ..
Health-Care Reform’s Final Hurdles
The House and the Senate are each trying to hammer out details in order to pass health-care bills before the August recess. But it’s a complicated and difficult process, WSJ’s Laura Meckler explains. ..
Medicare at 55: Widespread Approval for a Phantom Program
The public isn’t that into the health-care overhaul: In the latest WSJ/NBC poll , 44% of people say it would be better to keep the current system in place, and 41% say it would be better to pass the pending health-care legislation (the difference is within the poll’s margin of error). ..
Approval of Effient, a Plavix Rival, Boosts Japanese Drug Maker
The FDA just approved Effient , a blood thinner that will compete against the megablockbuster Plavix. The initial approval is for patients who undergo angioplasty (and typically get a stent) to unclog one or more arteries around the heart. Effient will carry a boxed warning alerting doctors and patients to the risk of serious bleeding..
As Health-Care Finale Gets Closer, Both Sides Boost Spending
It’s crunch time in the fight over a health-care bill, so groups for and against the legislation are getting ready for a final push before congressional votes that could come later this month. ..

Orshe