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EU clears AZ's FDA-rejected diabetes combination

Approval of two-drug therapy Qtern presents first-to-market advantage in Europe
AstraZeneca

The European Commission has approved AstraZeneca's Qtern, a two-drug therapy for type 2 diabetes that was turned down in the US last year.

Qtern combines the active ingredients in AZ's DPP-4 inhibitor Onglyza (saxagliptin) with SGLT2 inhibitor Farxiga/Forixiga (saxagliptin), and is the second drug of its type on the market after Eli Lilly and Boehringer Ingelheim's Glyxambi (linagliptin/empagliflozin).

Glyxambi debuted in the US last year but is not yet available in Europe, giving AZ first-mover advantage in the EU market.

Qtern brings together two of the fastest-growing type 2 diabetes drug classes, which have been shown in clinical trials to improve blood glucose control compared to older oral antidiabetic drugs (OADs), and is considered a key product in AZ's diabetes pipeline.

"Nearly half of all people with type 2 diabetes are unable to reach their treatment goal and so risk developing complications due to hyperglycaemia," said Elizabeth Björk, AZ's global head of cardiovascular and metabolic diseases development.

"Qtern is the first combination product of its kind approved in Europe and an important new treatment option to help patients reach their goals through powerful HbA1c reduction," she added.

The EU go-ahead is a boost for AZ, which looked at risk of losing its second place in the market after the FDA said last October it would need to see additional clinical data on the fixed-dose combination before it could consider approval.

Delay in the US could give other companies developing DPP-4/SGLT2 inhibitor combinations - such as Johnson & Johnson/Mitsubishi Tanabe and Merck/Pfizer - an opportunity to overtake AZ. However the EU approval gives the company a chance to make some headway with Qtern, which at one point was predicted to become a $3bn product at peak.

Since then however, Onglyza and certain other DPP4 inhibitors such as Takeda's Nesina (alogliptin) have been hit by a series of safety warnings from the FDA, including an increased risk of heart failure and joint pain.

The heart failure warning is particularly troublesome for AZ as it does not extend to Merck's top-selling DPP-4 inhibitor Januvia (sitagliptin), which is also being combined with SGLT2 inhibitor ertugliflozin in a fixed dose combination currently in late-stage testing.

A clean label suggests that sitagliptin/ertugliflozin will mount a strong challenge in the combination therapy category if it reaches the market.

Article by
Phil Taylor

20th July 2016

From: Regulatory

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