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FDA approves Farxiga generic Posted 23/08/2019

The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s diabetes medicine Farxiga (dapagliflozin). Patent issues, however, must be resolved before FDA grants full approval.

Dapagliflozin is a diabetes treatment that inhibits sodium-glucose transport proteins in the kidney. By blocking ~90% of glucose reabsorption in the kidney, glucose is instead eliminated in urine, thereby lowering the blood sugar levels of the patient. Dapagliflozin has also been shown to reduce the likelihood of heart attack and stroke in some patients. The drug is sold in the US by AstraZeneca under the trade name Farxiga.

In July 2019, FDA provided tentative approval to Novartis International AG (Novartis) to produce a biosimilar version of Farxiga. The drug generated sales of almost US$300 million for AstraZeneca in Q1.

AstraZeneca had submitted a supplemental new drug application (NDA) for Farxiga to allow the drug to be used to treat type 1 diabetes, based on clinical trial data showing improved glycaemic control in patients insufficiently responsive to insulin. FDA however rejected this application and responded with a complete response letter (CRL) in July 2019.

This news follows recent discussions regarding insulin pricing in the US, where FDA has announced plans to transition insulin products [1]. Insulin products were previously approved under the Food, Drug, and Cosmetic Act as drugs but from March 2020 will be considered biologicals. Following the trend, US pharma company Eli Lilly recently launched a lower-priced biosimilar version of its diabetes treatment Humalog (insulin lispro) [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s plans to transition insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products
2. GaBI Online - Generics and Biosimilars Initiative. Eli Lilly launches lower-priced insulin lispro [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 23]. Available from: www.gabionline.net/Biosimilars/General/Eli-Lilly-launches-lower-priced-insulin-lispro

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Source: US FDA

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