J&J's Invokana SNDA Gets Priority Review Status From FDA

Johnson & Johnson (NYSE:JNJ) announced that the FDA has granted priority review to a supplemental new drug application (sNDA) looking for label expansion of its type II diabetes medicine, Invokana. The sNDA is looking for approval of Invokana, a SGLT2 inhibitor, for slowing the progression of chronic kidney disease (CKD) in patients with type II diabetes when used in addition to standard of care.

The sNDA filing is based on data from the phase III CREDENCE renal outcomes study, data from which has shown that Invokana significantly reduces the risk of renal failure, dialysis or kidney transplantation, and renal or cardiovascular death in patients with type II diabetes and CKD.J&J had filed a sNDA in March to include data from the CREDENCE study on the label of Invokana.

We remind investors that in July last year, the study was stopped early based on positive pre-specified efficacy data. The decision was based on a recommendation from the study’s Independent Data Monitoring Committee (IDMC) that met to review the data during a planned interim analysis.

Almost half of all patients with type II diabetes develop CKD, causing a high risk of kidney failure and cardiovascular disease. If the sNDA is approved, Invokana will be the first new therapy in nearly 20 years to reduce the risk of kidney failure and prevent life-threatening cardiovascular events in patients with CKD and type II diabetes when added to current standard of care

In October last year, the U.S. label of Invokana was updated to include the cardiovascular outcomes data from the CANVAS program. With the label expansion, Invokana can now be prescribed to reduce the risk of cardiovascular events like heart attack, stroke or cardiovascular death in adults with type II diabetes and established cardiovascular disease. However, the label includes a warning about an increased risk of amputations.

Notably, many pharma companies are working hard to get the labels of their diabetes medicines updated to include renal outcomes data. A phase III study is evaluating Lilly’s (NYSE:LLY) successful SGLT2 inhibitor, Jardiance in CKD.

J&J’s shares have risen 7.5% this year so far against the industry’s decline of 0.9%.

J&J currently carries a Zacks Rank #3 (Hold).

Some better-ranked large-cap pharma stocks are Merck & Co., Inc. (NYSE:MRK) and AbbVie, Inc. (NYSE:ABBV) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Merck have gained 6% so far this year while estimates for 2019 and 2020 have risen 1.5% and 0.2%, respectively, over the past 30 days.

AbbVie’s earnings estimates for 2019 and 2020 have risen 1.5% and 1.4%, respectively, over the past 30 days.

Wall Street’s Next Amazon (NASDAQ:AMZN)

Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.

Click for details >>