Please login to the form below

Not currently logged in
Email:
Password:

J&J's Invokana receives new FDA safety warning

Additional trial data highlights bone problems
Johnson and Johson logo

Johnson & Johnson's Invokana has suffered a major setback as the FDA strengthened its warnings about the drug's effect on bone fractures.

The FDA's warnings state that the drug is related to an increased risk of bone fracture and added new information about its effect on bone mineral density.

Clinical trials of Invokana (canaglifozin) in 714 elderly patients showed that the drug caused a significantly greater loss of bone mineral density at the hip and lower spine than placebo. Fractures occurred as soon as 12 weeks after commencing the drug.

Invokana is a sodium-glucose cotransporter-2 (SGLT2) inhibitor used for type II diabetes and works by causing blood sugar to leave the body primarily through urine.

The drug was approved by the FDA in 2013 and was predicted to reach blockbuster status, with sales of $596m in the first half of this year. 

But the additional FDA warning could reduce its competitiveness as Invokana is already under pressure from Lilly and Boehringer Inglehiem's rival SGLT2 inhibitor.

The companies' Jardiance (empaglifozin) was just last month able to claim itself as the first diabetes drug able to lower risk of heart attack, stroke and cardiovascular disease, giving it a further edge over its competition.

However the FDA said in a statement: “We are continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapaglifozin (Farxia, Xigduo XR) and empagliflozin (Jardiance, Glyxambi, Synjardy) to determine if additional label changes or studies are needed.”

The US regulator urged health care professionals and patients to report side effects involving Invokana or other SGLT2 inhibitors, to its FDA MedWatch programme. 

Article by
Nikhil Patel

16th September 2015

From: Research, Regulatory

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Streaming Well

Streaming Well is a healthcare-focused, award-winning video production company which operates in the US and Europe. We create engaging visual...

Latest intelligence

Deep 6 AI: the smart software breathing new life into clinical trials
Fishawack Health interviews Wout Brusselaers, the Deep 6 AI CEO using artificial intelligence to solve one of the greatest barriers stagnating healthcare innovation—clinical trial recruitment and retention....
COVID-proof: How Teams are Creating Launch Intensity thru Adversity
Now that the game has changed, how are marketers shifting their launch behaviour? We've identified 5 common observations from effective teams....
5 ways that lockdowns and restrictions could be affecting our allergies
Over this last year, lockdowns and restrictions have led to changes in the day-to-day environments for people across the world. For Allergy Awareness week, we wanted to explore some of...