Janssen has launched its diabetes drug Invokana in the UK the same day it received backing from the National Institute for Health and Care Excellence (NICE) in draft guidance.
Janssen, the pharma division of Johnson & Johnson, said it will market Invokana (canagliflozin) in the UK in its approved indication to reduce blood sugar levels in people with type 2 diabetes who are unable to manage their condition through diet/lifestyle and other treatments, including metformin.
Use will be limited initially, however, as the drug is still to receive final positive guidance from NICE, which assesses the cost-effectiveness of drugs for use on the NHS in England and Wales.
Invokana is on course to receive this recommendation though as draft guidance released today supports the use of the drug as another option to treat some type 2 diabetes patients in the UK.
However, the draft guidance only recommends the use of Invokana if the drug is used as part of a dual therapy regimen in combination with metformin, if the person is at significant risk of hypoglycaemia or a sulfonylurea is contraindicated or not tolerated.
Invokana can also be used as part of a triple therapy regimen in combination with metformin and a sulfonylurea as well as in combination with insulin with or without other antidiabetic drugs.
If given final backing, Invokana would be the second sodium glucose co-transporter 2 (SGLT2) inhibitor recommended by NICE following its decision to back AstraZeneca’s Forxiga (dapagliflozin) last year.
SGLT2 inhibitors are a new class of type 2 diabetes treatment which block the re-absorption of glucose by the kidney, increasing the amount of glucose secreted in the urine. By working in this way, this therapy class has a lower risk of hypoglycaemia compared to other drugs, which affect blood sugar levels directly.
AZ and its former partner BMS won the race for first approval of this class of drugs in Europe when Forxiga was backed by the EMA in 2013.
However, Janssen took the honour in the US for Invokana after AZ and BMS had to resubmit their Forxiga application after an initial knock back from the FDA.
The draft NICE guidance for Invokana in type 2 diabetes is now up for consultation until March 17 after which further guidance will be issued.
In a busy few days, Janssen also announced at the end of last week that the EMA’s advisory board had recommended Invokana in combination with metformin in the form of Vokanamet.
The CHMP recommended the combined drug for approval to treat type 2 diabetes, potentially providing a more convenient treatment option for patients on both Invokana and metformin as separate drugs.