Johnson & Johnson (NYSE:JNJ) Says The US FDA Removes Boxed Warning For Its Invokana, A Diabetic Drug, After Recent Clinical Evidence Of Reduced Risk Of Amputation


The US FDA allowed the removal of boxed warning label for Invokana, a diabetes drug of Johnson & Johnson (NYSE:JNJ). Its decision is based on the recent clinical studies of the drug whose risk of amputation is reduced.

Invokana received approval in 2017

Johnson & Johnson’s diabetes drug – Invokana received FDA approval for use in adults with type 2 diabetes to reduce blood sugar levels. The drug is to be used along with exercise and diet to achieve the desired effects.

The health regulator said the use of Invokana also offers additional kidney and heart-related benefits. Johnson & Johnson reported a drop of 20% YoY to $790 million in sales in 2019.

Farxiga improves survival chances

Farxiga drug of AstraZeneca plc (NYSE:AZN) demonstrated survival chances for patients with kidney disease. The drug’s role is outside of its established diabetes field.

According to AstraZeneca, Farxiga reduced the chances of dying by 31% in people who suffer chronic disease, compared to people given the placebo. The drug is one of the best selling drugs for AstraZeneca.

In 2019, AstraZeneca reported sales of $1.54 billion for farxiga to cure diabetes. In the clinical study, the drug also showed an improvement of 39% in kidney functioning.

Around 700 million people across the world suffer from CKD (chronic kidney disease). Only limited options are available as of now to treat patients with CKD. It could lead to kidney failure, and patients need to undergo dialysis.

The head (R&D) of AstraZeneca, Mene Pengalos, said the company will discuss the US FDA to seek expanded use of farxiga to treat CKD in the next 5 months.

Farxiga, which belongs to the SGLT2 inhibitors class, is used to cure type 2 diabetes patients. It expels excessive glucose levels in the blood through urine by prompting kidneys. In the clinical trial, the drug also exhibited additional benefits for the heart. It expects to safeguard structures in your kidneys, which filters the blood.

AstraZeneca received approval for farxiga in May 2020 from the FDA to treat heart failure irrespective of its diabetes condition. AstraZeneca is also ahead of Invokana of Johnson & Johnson in enhancing the use of farxiga beyond diabetes.