FDA has approved a new diabetes drug from Johnson & Johnson, making it the first in its class to be approved in the United States.
The U.S. Food and Drug Administration approved the drug, Invokana, after data showed it was effective in lowering blood sugar in patients with Type 2 diabetes, the most common form of the disease.
The FDA has asked for five postmarketing studies for the drug including a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study and two pediatric studies, the agency said in a statement on its website. (r.reuters.com/juj96t)
Invokana is expected to generate sales in 2016 of around $468 million, according to analysts' estimates compiled by Thomson Reuters.
Known chemically as canagliflozin, Invokana is a member of a new class of diabetes treatments called sodium-glucose co-transporter-2 (SGLT2) inhibitors that lower blood sugar by blocking reabsorbtion of glucose and increasing its excretion in urine.
Earlier this year, an advisory committee to the FDA discussed the benefits and risks of canagliflozin with a focus on any potential increased risk of heart attack or stroke.
A clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event compared with just one patient taking a placebo. After that, the imbalance was reversed. The drug also caused a slight increase in unhealthy LDL cholesterol.
In January, 2012, the FDA rejected a similar drug, dapagliflozin, made by Bristol-Myers Squibb Co and AstraZeneca Plc, citing concerns over a possible increased risk of cancer and liver injury. The drug was subsequently approved in Europe under the brand name Forxiga.
In January 2013, Britain's National Institute for Health and Clinical Excellence (NICE), which decides whether drugs should be paid for on the state health service, declined to recommend that Forxiga be reimbursed and asked the companies for more information.
Diabetes affects the body's ability to metabolize glucose, which is needed for energy. Glucose circulates throughout the bloodstream, is filtered by the kidneys, and returned to body by glucose-specific transporters. By blocking the amount of glucose reabsorbed into the bloodstream, more is excreted in urine.
Left untreated, diabetes can cause nerve damage, kidney disease and blindness. It affects roughly 25.8 million people in the United States, according to the American Diabetes Association.
Despite FDA's rejection of dapagliflozin, and a broad association in the class with genital infections, several companies are still developing SGLT2 inhibitors, including Astellas Pharma Inc, which recently filed for Japanese approval of its ipragliflozin, and Boehringer Ingelheim and Eli Lilly & Company, which recently filed for U.S. approval of their drug, empagliflozin.
(Additional reporting by Sagarika Jaisinghani in Bangalore; Editing by David Gregorio)