FDA approves Farxiga
pharmafile | January 10, 2014 | News story | Sales and Marketing |Â Â AstraZeneca, BMS, FDA, Forxiga, diabetesÂ
The FDA has approved Farxiga, the diabetes treatment developed by AstraZeneca and Bristol-Myers Squibb as part of their soon-to-be-defunct diabetes alliance.
The drug, known as Forxiga (dapagliflozin) in Europe, was approved by the European Commission last year.
Farxiga/Forxiga is in the new class of diabetes treatments called selective sodium glucose co-transporter 2 (SGLT2) inhibitors, blocking the reabsorption of glucose by the kidney, thus increasing glucose excretion and lowering blood glucose levels.
Its novel mode of action makes it useful in a therapy area which retains a high level of unmet need, and it has been found to lower HbA1c and maintain glycaemic control in adults for two years.
However, the therapy is likely to face stiff competition in its class from Janssen’s Invokana (canagliflozin), which is still under review but which analysts predict could have peak sales of $1 billion.
In December the companies announced that AstraZeneca was to buy all of BMS’ interests in the companies’ diabetes alliance, in a potential $4.3 billion deal which is expected to go through before March this year.
AstraZeneca will pay an initial $2.7 billion for the deal and up to $1.4 billion in regulatory, launch and sales-related payments.
It has also agreed to pay various sales-related royalty payments up until 2025, and in addition the Anglo-Swedish firm may make payments up to $225 million when certain assets are transferred.
When the deal is done, AstraZeneca will own intellectual property and global rights for the development, manufacture and commercialisation of the diabetes business.
As well as Farxiga/Forxiga, this includes the blockbuster treatment Onglyza (saxagliptin), as well as Komboglyze (saxagliptin and metformin HCl) and Byetta (exenatide).
AstraZeneca and BMS say that around 4,100 BMS employees dedicated to the diabetes business will eventually move over to AstraZeneca.
Over time, AstraZeneca will also become responsible for the manufacturing and supply chain of the full portfolio of diabetes products. BMS will continue to deliver specified clinical trials in line with its ongoing clinical trial plan.
Adam Hill
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