J&J gets diabetes drug go-ahead

Johnson & Johnson, the world’s largest seller of healthcare products, won approval for the first in a new family of diabetes drugs, giving them the edge against rivals developing similar medicines.

The US Food and Drug Administration cleared the drug, known as canagliflozin, to treat adults with Type 2 diabetes, the agency said in a statement. It may generate $800m (€622m) in peak sales, Tony Butler, an analyst at Barclays Plc in New York, said.

The treatment, to be sold under the name Invokana, expels sugar in the urine after the kidneys filter it from the blood. The FDA has required J&J to conduct five post-market studies to track possible health risks, including to the heart, bones and pancreas.

“Bringing a new class to market is exciting,” said Kirk Ways, the drug’s development team leader. “We need to do better as a nation treating diabetes. Bringing canagliflozin to market will give patients and physicians another option.”

Invokana is part of a family of medicines known as SGLT2 inhibitors intended to have fewer side effects, such as low blood sugar and weight gain, than currently approved diabetes drugs. The firm is trying to beat to market similar drugs being developed by Eli Lilly & Co, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Co and AstraZeneca Plc.

For canagliflozin, J&J must study the medicine’s effect on patients’ hearts while the drug is on the market. J&J is working on a cardiovascular study called Canvas that the company plans to complete in 2017, Ways said.

Invokana probably will be used by doctors after patients fail current therapies, such as Merck & Co’s $4.1m Januvia, and cheaper generics including metformin, Butler said.

— Bloomberg