Roche diabetes pipeline shrinks to two

Share this article:

Roche's efforts to expand its cardiometabolic pipeline stalled Wednesday when the Swiss company announced it halted development of its experimental diabetes medication aleglitazar. The company said in a statement that an independent Data and Safety Monitoring Board recommended closing the study over “safety signals and lack of efficacy.”

The New York Times reports that these safety issues in the AleCardio study included increased risk of fractures, kidney problems and heart failure. Hints of potential kidney issues popped up in the 2012 results of the Phase II AleNephro study, which indicated that type 2 diabetes patients with moderate renal impairment experienced decreased renal function that was reversible.

The cohort for the AleCardio study comprised patients with a recent acute coronary event, but Roche said it will end all aleglitazar studies, meaning the other two in its pipeline line-up—cardiovascular risk reduction in type 2 or pre-diabetes, type two diabetes—are now wiped from the board of possible regulatory submission.

The drug's promise was threefold—its potential to reduce the risk of heart attack and stroke, as well as to keep an eye on glucose levels for type 2 diabetics. If successful, the drug could have enabled patients to knock out three major concerns with one medication. Aleglitazar attempted to do this by targeting two peroxiosome proliferator-activated receptors (PPARs), with one targeting triglycerides and another insulin sensitivity.

GlaxoSmithKline's Avandia, which belongs to a different class of PPAR agonists, focuses on insulin sensitivity. The FDA recently voted to lift restrictions put in place three years ago over Avandia's heart-risk concerns. Takeda's Actos, which acts on the same type of PPAR agonists as Avandia, has also been scrutinized for possible risks.

Roche is not the only one to fail in bringing a new PPAR agonist to market. Bristol-Myers Squibb bailed on a similar approach in 2005 after the FDA wanted additional data, while Takeda, Merck and AstraZeneca were forced to abandon similar efforts, over side effects including liver problems, tumors and kidney issues.

Roche is still studying two diabetes medications: dual agonist peptide analogue RG7697, which is similar to GLP-1 and GIP hormones, and the oral SGLT2 inhibitor tofogliflozin, in partnership with Chugai.

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

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

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 ...