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Janssen's Invokana combo smashes primary and secondary endpoints in chronic kidney disease

Janssen has unveiled promising new Phase 3 for its sodium-glucose transport (SGLT) protein-2 inhibitor Invokana (canagliflozin), showing that the therapy met its primary endpoint in the treatment of chronic kidney disease (CKD) and type 2 diabetes (T2D) when used in addition to standard of care.

In 4,401 participants with T2D or stage 2 or 3 CKD, the therapy reduced in the risk of progression to end-stage kidney disease (ESKD), doubling of serum creatinine, and renal or cardiovascular (CV) death by 30%.

J&J's Invokana becomes first FDA-approved oral diabetes drug to reduce cardiovascular event risk

The FDA has given the go-ahead for Johnson & Johnson’s drug Invokana (canagliflozin) for use in the risk reduction of major adverse cardiovascular (CV) events, making it the “first and only oral diabetes treatment approved with this indication”, according to the manufacturer.

This means the therapy is now authorised for the treatment of heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease.

J&J stops Invokana trial early after success in kidney disease and type 2 diabetes

Johnson & Johnson and research arm Janssen have taken the decision to terminate a Phase 3 trial evaluating the efficacy of its SGLT2 inhibitor Invokana (canagliflozin), but not because it had proved ineffective.

On the contrary, after the drug met its pre-specified efficacy criteria in the prevention of clinically important renal and cardiovadcvular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), the company deemed it pertinent to close the study early.

FDA issues warnings on Janssen, AstraZeneca diabetes drugs

The US Food and Drug Administration has issued a warning of the risk of acute kidney injury for the type-2 diabetes medicines Invokana (canagliflozin) and Farxiga (dapagliflozin), made by Janssen and AstraZeneca respectively.

This latest warning strengthens the existing guidance on these drugs. Invokana and Farxiga belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT-2) inhibitors which, by lowering blood sugar, can cause the kidneys to remove sugar through the body through urine.

NICE recommends Velcade for MCL, and three diabetes drugs

Janssen Velcade

NICE has published final guidance recommending Velcade (bortezomib) as a treatment for previously untreated mantle cell lymphoma (MCL). 

In the Phase III LYM‑3002 trial Velcade, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VR‑CAP), was shown to extend progression free survival (PFS) by 10.3 months compared to rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (R‑CHOP). Patients in the VR-CAP arm had a median PFS of 24.7 months, compared to 14.4 months for those treated with the R-CHOP combination.

FDA strengthens safety warning for J&J’s diabetes drug Invokana

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.

NICE recommends tenth diabetes drug

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In final guidance NICE has recommended Janssen’s Invokana as a treatment to help lower blood sugar levels in people with type 2 diabetes.

The oral, once-daily medication from the Johnson & Johnson subsidiary has been recommended as a treatment when taken with insulin, either alone or in combination with other antidiabetic drugs including metformin and sulfonylurea.

Janssen’s diabetes drug Invokana recommended

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An FDA advisory committee has recommended Janssen’s new diabetes treatment canagliflozin for approval.

To be marketed under the name Invokana, canagliflozin is in the new class of diabetes treatments called selective sodium glucose co-transporter 2 (SGLT2) inhibitors.

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