FDA backs Glenmark’s rival to AZ’s blockbuster Farxiga

AstraZeneca’s diabetes drug Farxiga could face generic competition in the US, after the FDA gave tentative approval to a generic rival from India’s Glenmark, although it is unclear when the potential competitor will be launched.

Glenmark gave no potential launch date for the generic approved by the FDA at 5 mg and 10 mg strengths.

AZ did not mention the impact of generic competition for Farxiga in the US in its full year earning statement earlier this year.

Farxiga (dapagliflozin) is used to treat type-2 diabetes, and AZ is aiming to build a substantial franchise around the drug after it also proved effective at reducing risk of hospitalisation and heart failure in patients with the disease.

The FDA is also quickly reviewing Farxiga to reduce risk of cardiovascular death or worsening of heart failure in adults with ejection fraction, with and without type 2 diabetes.

There are other related indications in the pipeline too, but the US patent on Farxiga is expected to expire this year.

An SGLT-2 inhibitor class drug, Farxiga, which is also branded as Forxiga in some countries, is becoming an important drug for AZ during a period when it is recovering from one of the industry’s worst patent cliffs.

Along with several new cancer drugs Farxiga has helped revive AZ’s fortunes and returned the company to growth.

According to figures from IQVIA cited by Glenmark, sales for the 12 month period ending 20 January were around $1.8 billion.

As well as potential competition from generics, AZ also has several other rivals from other big pharma companies.

Perhaps the most notable is Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin), which set new standards by becoming the first diabetes drug to show a benefit in reducing cardiovascular events in high-patients in 2015.

AZ developed Farxiga in partnership with Bristol-Myers Squibb, and fully acquired it by buying out the latter’s share in the partnership.

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