FDA strengthens safety warning for J&J’s diabetes drug Invokana
pharmafile | September 14, 2015 | News story | Sales and Marketing | FDA, Food and Drugs Administration, Invokamet, J&J, JJ, Johnson & Johnson, diabetes, invokana, safety warning, type 2 diabetes
Johnson & Johnson has suffered a blow after the FDA strengthened its safety warning for the company’s type 2 diabetes medicine Invokana.
The label for Invokana (canagliflozin) has carried a warning since the drug’s launch, concerning the risk of bone fracture. Now additional clinical trial data requested by the FDA confirmed this risk, as well as a risk of decreased bone mineral density at the hip and lower spine.
As a result, a new warning has been added to the warning and precaution section of the Invokana and Invokamet (canagliflozin and metformin) drug labels, and a revision made to the adverse reactions section.
Invokana belongs to a class of type 2 diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. It lowers patients’ blood sugar levels by blocking glucose reabsorption and causing the kidneys to remove sugar from the body through the urine.
The FDA approved Canagliflozin- the first drug approved in the SGLT2 class- in 2013, but requested five post-marketing studies, including a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study and two paediatric studies.
The two-year bone safety study of 714 elderly individuals found patients taking Invokana lost more bone density in their hips and lower spine than those taking a placebo, and that fractures can occur as early as 12 weeks after starting the drug.
The FDA did however point out that the pre-fracture trauma observed in during the clinical trials was usually minor, such as falling from no more than standing height.
But the additional warning will come as a blow to J&J, as strong sales of Invokamet had been a positive amidst recent disappointing financial results, which included a $7.9 billion fall in sales in Q2 2015. The drug has already achieved close to $600 million in sales for the first half of 2015 alone.
The FDA has now advised that healthcare professionals take the confirmed risks into account before prescribing canagliflozin to patients, which could affect sales in an increasingly competitive market.
The entire diabetes type 2 drugs market has come under scrutiny of late, with the dipeptidyl peptidase-4 (DPP-4) inhibitor class also attracting safety warnings from the FDA after several cases of severe joint pain were reported by patients taking Merck’s Januvia (sitagliptin) and Janumet (sitagliptin and metformin) and AstraZeneca’s Onglyza (saxagliptin). This prompted the FDA to issue a warning for the whole DPP-4 class regarding the risk of joint pain.
Joel Levy
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