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SGLT2 Inhibitor Approvals and Updates

Johnson & Johnson’s SGLT2 canagliflozin (Invokana) has just received FDA approval, while Boehringer Ingelheim and Eli Lilly submit their SGLT2 inhibitor (empagliflozin) to the FDA….

U.S. health regulators have 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. Invokana is expected to generate sales in 2016 of around $468 million, according to analysts’ estimates.

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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.

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.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

At the same time the FDA approves the first SGLT-2, Boehringer Ingelheim and Eli Lilly and Company have reported top-line results for four completed phase III clinical trials for empagliflozin.

These four pivotal studies from the empagliflozin trial program includes: Study 1245.20 (n=986) evaluated 10 mg and 25 mg doses of empagliflozin as monotherapy versus placebo for 24 weeks. Study 1245.23 (n=1,504) compared 10 mg and 25 mg doses of empagliflozin as an add-on to metformin and metformin plus sulfonylurea versus placebo for 24 weeks. Study 1245.19 (n=499) assessed 10 mg and 25 mg doses of empagliflozin as an add-on to pioglitazone and pioglitazone plus metformin versus placebo for 24 weeks. Study 1245.36 (n=741) evaluated 25 mg dose of empagliflozin in patients with type 2 diabetes with mild, moderate or severe renal impairment, and 10 mg dose in those with mild renal impairment versus placebo for 52 weeks.

Incidence of adverse events was similar for placebo, empagliflozin 10mg and 25mg. Genital infections occurred more often with empagliflozin (both dosages) compared with placebo. This safety information is consistent with findings reported in the phase II study results for empagliflozin.

Compiled from Eli Lilly, J&J Press Releases