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ADA: AZ plans to file Onglyza/Forxiga pill by year-end

Diabetes prospects could help justify decision to turn down Pfizer bid
AstraZeneca ADA

AstraZeneca (AZ) continued to assert its independence in the wake of Pfizer's failed takeover bid with a strong demonstration of its prospects in type 2 diabetes at the weekend, including plans to file a combination of two of its major treatments by the end of 2014.

Coming just weeks after the company showcased several strong prospects in cancer at ASCO in Chicago, AZ used the American Diabetes Association meeting in San Francisco to present data from several key trials conducted as part of its aim to become leaders in the field of non-insulin diabetes treatments.

Leading the field was a phase III trial investigating a combination of two of its main treatments: Forxiga (dapagliflozin) and Onglyza (saxagliptin), both of which are approved as individual treatments for type 2 diabetes.

Data from the trial demonstrated that, when taken by patients who had failed to control their blood sugar levels on metformin, the combination treatment was able to help 40 per cent of patients of get to a goal blood sugar level of less than 7 HbA1c. This is twice as many patients that achieved this rate as those on Forxiga or Onglyza as individual treatments.

Speaking to PMLiVE, AZ's VP, late clinical development Elizabeth Bjork confirmed the company plans to file this combination for approval in the US and Europe by the year-end.

As for where the drug might fit on the treatment pathway for patients with type 2 diabetes, Bjork said the drug could be used directly after metformin, slowing down the start of insulin for patients unable to control blood sugar levels.

“The beauty with this study is that we gave this combination early on, right after failure on metformin,” said Bjork. “That is a very good starting place.”

Greater and earlier use of combination treatments is something that will be more common in diabetes treatment, according to Bjork, reflecting similar comments made recently by AZ's head of oncology R&D Susan Galbraith in relation to cancer.

“Combinations are the future,” said Bjork. “We will move toward starting treatment earlier, and then keep them for longer period of time at goal.”

AZ is strongly positioned to do this, according to Bjork, with the decision to take complete control of a former alliance with Bristol-Myers Squibb (BMS) giving the company a wide portfolio in type 2 diabetes.

“When you get to place where you consider injections, we have had Bydureon and other exenatide products on the market now for some time. Through combinations of all these things we will be able to find a good treatment for most patients, you could delay use of insulin by some time.”

One issue that could hinder the prospects of the combination of Forxiga and Onglyza is an ongoing US investigation into an increased risk in heart failure associated with Onglyza as an individual treatment.

Bjork confirmed that any change in the regulatory profile of Onglyza would be incorporated into the combination treatment, although she also described Onglyza as a “very safe drug” based on the total data associated with it.

“It's important to understand that patients who developed heart failure were at much higher risk, so they had characteristics that made them more prone to the condition,” she said.

Article by
Thomas Meek

16th June 2014

From: Sales



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