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UPDATED: J&J wins first FDA approval for new class of diabetes drug

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The FDA has approved the first drug in a new class of blood glucose-lowering diabetes drugs. Johnson & Johnson ($JNJ) won the agency's nod for Invokana (canagliflozin) for patients with Type II diabetes, giving the healthcare giant its first market green light for a new diabetes therapy. Yet U.S. regulators have mandated that J&J complete a cardiovascular outcomes trial and four other postmarketing studies as a condition of the approval, and the agency advised against use of the drug in patients with kidney disease

Paul Stoffels

Johnson & Johnson has one of the world's largest pharma businesses, but until now Janssen chief Paul Stoffels was without a product to anchor a highly desirable diabetes franchise. It took a gigantic development effort, as most diabetes programs do. Invokana was tested in 9 late-stage studies involving more than 10,000 patients, making it the largest R&D effort of its kind in the history of the pharma business.

Invokana is the first FDA-approved therapy from the hotly pursued class of drugs called SGLT2 inhibitors, which block a protein involved in glucose reabsorption in the kidneys, enabling blood sugar to exit the body in urine. Early last year U.S. regulators rejected a similar drug from AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) called Forxiga over safety worries, but that therapy went on to gain the first approval in the drug class in Europe. Major diabetes players Sanofi ($SNY), Eli Lilly ($LLY) and others have their own SGLT2 candidates in late-stage development.

Yet Invokana comes with some safety risks. It lowered blood sugar but raised cholesterol in patients in clinical trials. Prior to today's decision, FDA reviewers highlighted the increased risk of cardiovascular problems to patients on the therapy, which has also been associated with higher rates of urinary tract and vaginal infections, high blood pressure and unhealthy drops in blood sugar.

Some analysts quickly latched on to suggest that those side effects could severely curtail the size of the prospective market for this drug, along with any other SGLT-2 drugs in development, like Eli Lilly's empagliflozin, partnered with Boehringer. "We have modest expectations for Invokana and the SGLT-2 class because the drug and class are associated with a relatively high rate of genital infections which will limit uptake in our view," noted Wells Fargo analyst Lawrence Biegelsen, according to a post from Matthew Herper at Forbes.

The FDA has a history of holding diabetes drugs to high standards on safety after some past health disasters with new diabetes drugs injured the reputation of the agency and endangered patients. Despite the risks of new treatments, healthcare providers have stayed open to innovative methods to combat the growing diabetes epidemic, which affects about 26 million Americans, with many patients struggling to control their blood sugar levels and suffering complications such as heart disease and organ damage.

"We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

In addition to carrying out the postmarket studies, J&J faces the challenge of pitching the new therapy to physicians who have no experience in prescribing the drug. The Janssen group plans to partner with other J&J units with experience in the diabetes market. At least for now, J&J has the price nailed down. 

"Wholesale acquisition cost for Invokana 100 mg and 300 mg is $8.77 per day making it competitive in the marketplace to other currently available anti-hyperglycemic agents," J&J spokeswoman Christina Holden said in an email to FierceBiotech.

- here's the FDA's release

Special Reports: Paul Stoffels - The 25 most influential people in biopharma today - 2013 | Top diabetes drug pipelines of 2012

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