he FDA has declined to approve AstraZeneca’s New Drug Application (NDA) for the investigational fixed-dose combination of Onglyza and and Forxiga for the treatment of adult patients with type 2 diabetes.
The administration issued a Complete Response Letter (CRL), stating that more clinical data are required to support the application. This includes clinical trial data from ongoing or completed studies and may require information from new studies.
AstraZeneca said it would work closely with the FDA to determine the appropriate next steps for the NDA and that it “remains committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination,” yet the CRL will come as a blow to the company, which had regarded the combination as a potential blockbuster.
When trying to find off Pfizer’s $118 billion takeover bid last year AstraZeneca claimed the Onglyza/Forxiga (saxagliptin/dapagliflozin) combination could generate peak annual sales of up to $3 billion of its total diabetes revenue of $8 billion anticipated by 2023.
AZ said the FDA rejection would not affect ongoing interaction with other health authorities, or components of saxagliptin or dapagliflozin individually, which are approved for type 2 diabetes and sold under the brand names Onglyza and Farxiga.
Onglyza, a DPP-IV inhibitor, achieved sales of $391 million in the first half of 2015, and Farxiga – an SGLT2 inhibitor – hit $205 million.