AstraZeneca and Novartis score major new approvals

May 7, 2020

AstraZeneca and Novartis reported drug approvals for two significant indications this week.

Farxiga, AstraZeneca’s blockbuster diabetes drug, has now been approved by the FDA to treat heart failure. Analysts predict that the new indication could boost Farxiga’s sales from $1.54 billion last year to about $3 billion by 2024.

The FDA’s nod was based on results from a late-stage study showing that Farxiga reduced the chance of cardiovascular death or hospitalization for patients who have experienced heart failure. 

Farxiga is an SGLT2-inhibitor that lowers blood sugar by inhibiting the reabsorption of glucose in the kidney. This class of drugs has most commonly been used on type 2 diabetes patients, but the AstraZeneca nod could pave the way for other companies, such as Eli Lilly and Johnson & Johnson, to get their SGLT-2 inhibitors approved for new indications. 

Novartis, meanwhile, notched a win on its quest to get its drug, Tabrecta, approved for a new cancer indication. The company announced this week that the drug has been given the go-ahead for patients with METex14 mutated non-small cell lung cancer (NSCLC) that has metastasized. 

Tabrecta is the first drug to win approval for the indication, beating out a rival from Pfizer.

Although NSCLS accounts for about 85 percent of the new lung cancer diagnoses each year, only about 4,000-5,000 patients have the METex14 mutation. But pharma companies have been increasingly focused on targeting specific biomarkers in oncology drug development, which can prove more effective against the disease.