Roche halts investigation of aleglitazar

RocheRoche (SIX: RO, ROG; OTCQX: RHHBY) announced that following the results of a regular safety review of the aleglitazar AleCardio phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended to halt the trial due to safety signals and lack of efficacy. Based on this recommendation, Roche has decided to terminate the AleCardio trial and all other trials involving aleglitazar.

"The safety of patients is our first priority. Roche is working with investigators to support the management of patients and their transition from aleglitazar treatment to other blood sugar control therapies," said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development. "We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with type 2 diabetes who are at risk of cardiovascular disease."

The AleCardio trial evaluated the efficacy and safety of aleglitazar in patients with a recent acute coronary syndrome event and type 2 diabetes. The data from the trial will be further analysed to fully understand the findings and will be made available at a future medical meeting.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Most Popular Now

New analysis shows Novartis Entresto improves glyc…

Novartis has announced results of a new post-hoc analysis in a subgroup of patients with reduced ejection fraction heart failure (HFrEF) and diabetes suggesting that Entr...

Read more

Mutual Recognition promises new framework for phar…

The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under t...

Read more

Potential drug candidates halt prostate and breast…

Scientists on the Florida campus of The Scripps Research Institute (TSRI) have designed two new drug candidates to target prostate and triple negative breast cancers. The...

Read more

Novartis' Cosentyx shows almost all psoriasis pati…

Novartis has announced a new analysis showing that moderate-to-severe psoriasis patients treated with Cosentyx® (secukinumab) rapidly regain clear or almost clear skin (P...

Read more

Scientists stimulate immune system, stop cancer gr…

Researchers at the University of Illinois at Chicago report that increasing expression of a chemical cytokine called LIGHT in mice with colon cancer activated the immune ...

Read more

Johnson & Johnson completes acquisition of Abb…

Johnson & Johnson (NYSE: JNJ) has completed the acquisition of Abbott Medical Optics (AMO), a wholly-owned subsidiary of Abbott. The all-cash $4.325 billion acquisition w...

Read more

New England Journal of Medicine publishes long-ter…

In 2001 the U.S. Food and Drug Administration granted priority review for imatinib mesylate, sold under the name Gleevec®*, as an oral therapy for patients with chronic m...

Read more

Bristol-Myers Squibb expands focus on precision me…

Bristol-Myers Squibb Company (NYSE: BMY) announced its equity investment and plans for a research collaboration with GRAIL Inc., a life sciences company whose mission is ...

Read more

Volkswagen's excess emissions will lead to 1,200 p…

In September 2015, the German Volkswagen Group, the world's largest car producer, admitted to having installed "defeat devices" in 11 million diesel cars sold worldwide b...

Read more

MedImmune and Sanofi Pasteur form alliance to deve…

MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, have announced an agreement to develop a...

Read more

Cooking at home tonight? It's likely cheaper and h…

Researchers from the University of Washington School of Public Health have been peeking into kitchens - via interviews - for years now. They've just published results sho...

Read more

Human antibody for Zika virus promising for treatm…

Researchers have determined the structure of a human antibody bound to the Zika virus, revealing details about how the antibody interferes with the infection mechanism - ...

Read more

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]