FDA Approves Boehringer Ingelheim’s Diabetes Drug Jardiance

The US Food and Drug Administration has approved Boehringer Ingelheim’s Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose (blood sugar) by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels.

Jardiance is also approved in Europe and Australia. It is part of the diabetes alliance between Boehringer Ingelheim and Eil Lilly, which was formed in 2011. Boehringer Ingelheim  and Eli Lilly resubmitted the new drug application for empagliflozin in June 2014 following a complete response letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

In April 2014, the Eli Lilly and Boehringer reported that the FDA had accepted their NDA for a combination tablet of empagliflozin and linagliptin for the treatment of adults with Type 2 diabetes. If granted approval by FDA, the combination would offer the mechanisms of action of a SGLT2 inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor. SGLT2 inhibitors remove excess glucose through the urine by blocking glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

Jardiance is the third SGLT2 inhibitor.to treat Type II diabetes approved by the FDA. In January 2014, AstraZeneca received FDA approval for Farxiga (dapaglifozin), and Janssen Pharmaceuticals' Invokana (canagliflozin) was approved in 2013. AstraZeneca gained full rights to Farxiga as part of its $2.7-billion acquisition of its diabetes alliance with Bristol-Myers Squibb, a deal which was completed in February 2014.

Other pharmaceutical companies have late-stage SGLT2 inhibitors in development. Pfizer and Merck & Co are developing their SGLT2 inhibitor, ertugliflozin, which is in Phase III trials. In April 2013, Pfizer and Merck formed a collaboration agreement for the development and commercialization of Pfizer's ertugliflozin. The companies are collaborating on the clinical development and commercialization of ertugliflozin and ertugliflozin-containing fixed-dose combinations with metformin and Merck's Januvia (sitagliptin) tablets. Merck will continue to retain the rights to its existing portfolio of sitagliptin-containing products. Pfizer received an upfront payment and milestones of $60 million and will be eligible for additional payments associated with the achievement of pre-specified future clinical, regulatory, and commercial milestones. Merck and Pfizer will share potential revenues and certain costs on a 60/40 percent basis.

In January 2014, Astellas Pharma received marketing approval in Japan for its SGLT2 inhibitor Suglat (ipragliflozin L-proline). In April 2014, the Japanese pharmaceutical company Taisho Pharmaceutical received manufacturing and marketing approval in Japan for its SGLT2 inhibitor Lusefi (luseogliflozin) for treating Type II diabetes.

Among smaller companies, Islet Sciences, a biopharmaceutical company based in Raleigh, North Carolina, announced a letter of intent to acquire BHV Pharma, based in Research Triangle Park, North Carolina, which is developing the SGLT2 inhibitor remogliflozin etabonate for the treatment of Type II diabetes. Lexicon Pharmaceuticals, Inc., based in Princeton, New Jersey, has an SGLT2 inhibitor, LX4211,in Phase II clinical trials.

Source: FDA   and company information

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